Institute of Pharmaceutical Sciences Kurukshetra University ... · PDF fileInstitute of...

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Institute of Pharmaceutical Sciences Kurukshetra University, Kurukshetra Scheme of Examinations M. Pharm. Course Structure (2013-2014) Specialization: Pharmaceutics Paper Code Subject Hours/Week Sessional Final Max. Marks Exam Hours Examination Examination Marks Marks Semester –I MPH-101 Modern Pharmaceutical and Analytical Techniques 4 20 80 100 3 MPH-102 Modern Pharmaceutical and Analytical Techniques Practical 4 20 80 100 4 MPH-111 Pharmaceutics - I 4 20 80 100 3 (Product Development and Quality Assurance) MPH-112 Pharmaceutics -II 4 20 80 100 3 (Advanced Pharmaceutics-I) MPH-113 Pharmaceutics - III 4 20 80 100 3 (Advances in Drug Delivery Systems - I) MPH–114 Pharmaceutics Practical –I 12 30 120 150 6 Total 32 130 520 : 650 Semester-II MPH-201 Biostatistics and Intellectual Property Rights 4 20 80 100 3 MPH-211 Pharmaceutics – IV 4 20 80 100 3 (Biopharmaceutics & Advanced Pharmacokinetics) MPH-212 Pharmaceutics –V 4 20 80 100 3 (Advanced Pharmaceutics-II) MPH-213 Pharmaceutics – VI 4 20 80 100 3 (Advances in Drug Delivery Systems - II) MPH-214 Pharmaceutics Practical – II 12 30 120 150 6 Total 28 110 440 550 Semester-III Seminar / Presentation Total 50 Semester-IV Thesis Evaluation 50 Viva-Voce 100 150 Grand Total: 1400

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Page 1: Institute of Pharmaceutical Sciences Kurukshetra University ... · PDF fileInstitute of Pharmaceutical Sciences Kurukshetra University, Kurukshetra Scheme of Examinations M. Pharm.

Institute of Pharmaceutical Sciences Kurukshetra University, Kurukshetra

Scheme of Examinations M. Pharm. Course Structure (2013-2014)

Specialization: Pharmaceutics Paper Code Subject Hours/Week Sessional Final Max. Marks Exam Hours Examination Examination Marks Marks Semester –I MPH-101 Modern Pharmaceutical and Analytical Techniques 4 20 80 100 3 MPH-102 Modern Pharmaceutical and Analytical Techniques Practical 4 20 80 100 4

MPH-111 Pharmaceutics - I 4 20 80 100 3 (Product Development and Quality Assurance) MPH-112 Pharmaceutics -II 4 20 80 100 3 (Advanced Pharmaceutics-I) MPH-113 Pharmaceutics - III 4 20 80 100 3 (Advances in Drug Delivery Systems - I) MPH–114 Pharmaceutics Practical –I 12 30 120 150 6

Total 32 130 520 : 650 Semester-II

MPH-201 Biostatistics and Intellectual Property Rights 4 20 80 100 3 MPH-211 Pharmaceutics – IV 4 20 80 100 3 (Biopharmaceutics & Advanced Pharmacokinetics) MPH-212 Pharmaceutics –V 4 20 80 100 3 (Advanced Pharmaceutics-II) MPH-213 Pharmaceutics – VI 4 20 80 100 3 (Advances in Drug Delivery Systems - II) MPH-214 Pharmaceutics Practical – II 12 30 120 150 6 Total 28 110 440 550 Semester-III Seminar / Presentation Total 50

Semester-IV Thesis Evaluation 50 Viva-Voce 100 150 Grand Total: 1400

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Kurukshetra University, Kurukshetra Scheme of Examinations

M. Pharm. Course Structure 2013-2014

Specialization: Pharmaceutical Chemistry Paper Code Subject Hours/Week Sessional Final Max. Marks Exam Hours Examination Examination Marks Marks Semester –I MPH-101 Modern Pharmaceutical and Analytical Techniques 4 20 80 100 3 MPH-102 Modern Pharmaceutical and Analytical Techniques Practical 4 20 80 100 4 MPH-121 Pharmaceutical Chemistry –I 4 20 80 100 3 (Advanced Organic Chemistry) MPH-122 Pharmaceutical Chemistry II 4 20 80 100 3 (Advanced Natural Products Chemistry-I) MPH-123 Pharmaceutical Chemistry – III 4 20 80 100 3 (Advanced Medicinal Chemistry - I) MPH–124 Pharmaceutical Chemistry Practical –I 12 30 120 150 6 Total 32 130 520 : 650 Semester-II MPH-201 Biostatistics and Intellectual Property Rights 4 20 80 100 3 MPH-221 Pharmaceutical Chemistry – IV 4 20 80 100 3 (Advanced Spectral & Analytical Techniques) MPH-222 Pharmaceutical Chemistry –V 4 20 80 100 3 (Advanced Medicinal Chemistry- II) MPH-223 Pharmaceutical Chemistry – VI 4 20 80 100 3 (Advanced Natural Products Chemistry - II) MPH-224 Pharmaceutical Chemistry Practical – II 12 30 120 150 6 Total 28 110 440 550 Semester-III Seminar /Presentation Total 50 Semester-IV Thesis evaluation 50 Viva-voce 100

Grand Total: 1400

Total 150

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Kurukshetra University, Kurukshetra Scheme of Examinations

M. Pharm. Course Structure 2013-2014

Specialization: Pharmacology Paper Code Subject Hours/Week Sessional Final Max. Marks Exam Hours Examination Examination Marks Marks Semester –I MPH-101 Modern Pharmaceutical and Analytical Techniques 4 20 80 100 3 MPH-102 Modern Pharmaceutical and Analytical Techniques Practical 4 20 80 100 4 MPH-131 Pharmacology-I 4 20 80 100 3 (Pharmacology and Pharmacotherapeutics) MPH-132 Pharmacology-II 4 20 80 100 3 (Drug Evaluation Techniques) MPH-133 Pharmacology-III 4 20 80 100 3 (Drug Discovery and Toxicology) MPH–134 Pharmacology Practical –I 12 30 120 150 6 Total 32 130 520 : 650 Semester-II MPH-201 Biostatistics and Intellectual Property Rights 4 20 80 100 3 MPH-231 Pharmacology- IV 4 20 80 100 3 (Clinical Pharmacology and Regulatory Toxicology) MPH-232 Pharmacology–V 4 20 80 100 3 (Cellular and Molecular Pharmacology) MPH-233 Pharmacology– VI 4 20 80 100 3 ( Recent Advances in Pharmacology) MPH-234 Pharmacology Practical – II 12 30 120 150 6 Total 28 110 440 550 Semester-III Seminar /Presentation Total 50 Semester-IV Thesis evaluation 50 Viva-voce 100

Grand Total: 1400

Total 150

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Institute of Pharmaceutical Sciences, Kurukshetra University, Kurukshetra Scheme of Examinations

M. Pharm. Course Structure (Session 2013-2014) Specialization: Pharmacognosy and Phytochemistry

Paper Code Subject Hours/Week Sessional Final Max. Marks Exam Hours Examination Examination Marks Marks Semester –I MPH-101 Modern Pharmaceutical and Analytical Techniques 4 20 80 100 3 MPH-102 Modern Pharmaceutical and Analytical Techniques Practical 4 20 80 100 4 MPH-141 Pharmacognosy –I 4 20 80 100 3 (Natural Product Drug Discovery) MPH-142 Pharmacognosy- II 4 20 80 100 3 (Extraction and Isolation of Herbal Drugs) MPH-143 Pharmacognosy –III 4 20 80 100 3 (Standardization and Regulatory Affairs of Herbal Drugs) MPH–144 Pharmacognosy -I Practical 12 30 120 150 6 Total 32 130 520 : 650 Semester-II MPH-201 Biostatistics and Intellectual Property Rights 4 20 80 100 3 MPH-241 Pharmacognosy-IV 4 20 80 100 3 (Characterization of Phytoconstituents) MPH-242 Pharmacognosy-V 4 20 80 100 3 (Herbal Drug Development and Formulation) MPH-243 Pharmacognosy-VI 4 20 80 100 3 (Advanced Pharmacognosy) MPH-244 Pharmacognosy-IV Practical 12 30 120 150 6 Total 28 110 440 550 Semester-III Seminar /Presentation Total 50 Semester-IV Thesis evaluation 50 Viva-voce 100

Grand Total: 1400

Total 150

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Kurukshetra University, Kurukshetra Scheme of Examinations

M. Pharm. Course Structure 2013-2014

Specialization: Pharmaceutical Management Paper Code Subject Hours/Week Sessional Final Max. Marks Exam Hours Examination Examination Marks Marks Semester –I MPH-101 Modern Pharmaceutical and Analytical Techniques 4 20 80 100 3 MPH-102 Modern Pharmaceutical and Analytical Techniques Practical 4 20 80 100 4 MPH-151 Management Concepts and Organizational Behaviour 4 15 60 75 3 MPH-152 Pharmaceutical Marketing Management 4 15 60 75 3 MPH-153 Accounting and financial management 4 15 60 75 3 MPH-154 Managerial Economics 4 15 60 75 3 MPH–155 Soft Skills Development 2 20 --- 20 -- MPH–156 Soft Skills Development Practical 2 30 --- 30 -- Total 28 150 400 : 550 Semester-II MPH-201 Biostatistics and Intellectual Property Rights 4 20 80 100 3 MPH-251 International Business Management 4 15 60 75 3 MPH-252 Materials Production and Product Management 4 15 60 75 3 MPH-253 Business Laws and Regulatory affairs 4 15 60 75 3 MPH-254 Strategic and Brand Management 4 15 60 75 3 MPH-255 Sales and Retail Management 4 15 60 75 3 MPH-256 Hospital Management and Administration 4 15 60 75 3 Total 28 110 440 550 Semester-III - Training report + Presentation (viva-voce) 50+50 marks 100 Semester-IV Thesis evaluation 50 Viva-voce 150

Grand Total: 1400

Total 200

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INSTITUTE OF PHARMACEUTICAL SCIENCES, KURUKSHETRA UNIVERSITY KURUKSHETRA

Syllabus: M. Pharm. (Pharmaceutical Chemistry) First Semester

Paper – I

MPH - 101: MODERN PHARMACEUTICAL AND ANALYTICAL TECHNIQUES 4 hours/week Max. Marks 80 Note: The paper setter will set 7 questions (First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus; three question from section A and one question from each section B, C and D); out of which the candidate will be required to attempt 5 questions in all and atleast one question from each section. All questions will carry equal marks. A. Pharmaceutical Chemistry (27h)

1. Infrared Spectroscopy (4h) Introduction, the infrared absorption process, the modes of vibrations, stretching and bending, bond properties and absorption trends, basics of instrumentation techniques, pharmaceutical applications.

2. Ultraviolet Spectroscopy (3h) Introduction, the nature of electronic excitation, the origin of uv band structure, principle of absorption spectroscopy, chromophore- σ→σ*, η→σ*, π→π* transitions, basics of instrumentation techniques, pharmaceutical applications.

3. Nuclear Magnetic Resonance Spectroscopy (4h) Introduction, nuclear spin states, nuclear magnetic moments, absorption of energy, the mechanism of resonance, chemical equivalence, spin-spin coupling, basics of instrumentation techniques, pharmaceutical applications.

4. Mass Spectrometry (5h) Basic principle and theory involved, basics of instrumentation techniques, pharmaceutical applications.

5. Thermal Analysis (7h) Introduction to various thermal methods of analysis, basic principles and theory, instrumentation and pharmaceutical applications of thermo gravimetric analysis (TGA), differential thermal analysis (DTA), differential scanning calorimetry (DSC) and microcalorimetry, different types of calorimeters and micro calorimeters, advantages of microcalorimetry over DSC.

6. Optical Rotatory Dispersion and Circular Dichroism (4h) Definition, theory and instrumentaton of ORD and CD. Cotton effect, Octant rule and its applications B. Pharmaceutics (13h)

1. Basic elements of Novel drug delivery systems. 2. Bioavailability and bioequivalence testing, significance of terminology, conduct of bioavailability

trials. 3. Introduction to validation of manufacturing facilities I.Q. / O.Q. and certification, preparation of

validation protocols. 4. Stability testing: Stress testing of drug substances, stability testing protocols, shelflife

determination, ICH guidelines. C. Pharmacognosy (10h)

Plant tissue culture: Conventional breeding v/s tissue culture, Applications of Plant tissue culture technique,Tissue culture media (composition & preparation), Preparation of explant, Sterilization techniques, Type of cultures, Protoplast technology and its applications, Immobilization techniques and their applications, Tissue culture as a technique to produce novel plants and hybrids, Factors affecting the production of secondary metabolites from tissue- culture.

D. Pharmacology (10h) Definition of bioassay, various types of bioassays, advantages and limitations of bioassays with suitable examples, Theory and application of radioimmunoassay and ELISA. Animal models for screening of anti-inflammatory, anti-convulsant, and anti-diabetic.

Reading Material Recommended

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1. Silverstein RM and Webster FX. Spectrometric Identification of Organic Compounds. John Wiley and Sons, New York. Latest Edition.

2. Pavia DL, Lampman GM and Kriz GS. Introduction to Spectroscopy. Harcourt College Publishers, Orlando. Latest Edition.

3. Vogel HG and Vogel WH. Drug Discovery and Evaluation. Springer-Verlag, Berlin. Latest Edition. 4. Kulkarni SK. Handbook of Experimental Pharmacology. Vallabh Prakashan, New Delhi. Latest Edition. 5. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata. Latest Edition. MPH 102: MODERN PHARMACEUTICAL AND ANALYTICAL TECHNIQUES PRACTICAL 4 Hours/week Max. Marks: 80

Modern experiments having relevance to the topics covered under theory.

Reading Material Recommended 1. Indian Pharmacopoeia, Central Indian Pharmacopoeia Laboratory, Govt. of India, Ministry of Health &

Family Welfare, Ghaziabad, Latest Edition. 2. U. S. Pharmacopoeia – NF, The United States Pharmacopoeial Convention, Rockville, USA, Latest

Edition. 3. European Pharmacopoeia, Directorate for the Quality of Medicines of the Council of Europe

(EDQM), Strasbourg, Europe, Latest Edition. 4. British Pharmacopoeia, The Stationary Office on behalf of the Medicine Health Care Product

Regulatory Agency (MHRA), London, Latest Edition. 5. Mendham J, Denney RC, Barnes JD and Thomas M. Vogel’s Textbook of Quantitative Chemical

Analysis. Pearson Education Limited, Singapore. Latest Edition. 6. Silverstein RM and Webster FX. Spectrometric Identification of Organic Compounds. John Wiley and

Sons, New York. Latest Edition. 7. Vogel HG and Vogel WH. Drug Discovery and Evaluation. Springer-Verlag, Berlin. Latest Edition. 8.

Kulkarni SK. Handbook of Experimental Pharmacology. Vallabh Prakashan, New Delhi. Latest Edition. 9. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata. Latest Edition. MPH - 121: PHARMACEUTICAL CHEMISTRY – I

(ADVANCED ORGANIC CHEMISTRY) 4 Hours/week Max. Marks - 80 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. 1. Reactive intermediates in organic synthesis.

a) Carbocations: Formation, structure, stability and reactions of carbocations. Rearrangement reactions like, Wagner-Meerwein, Beckmann rearrangement and pinacol-pinacolone.

b) Carbanions: Formation, structure, stability and reactions of carbanions. Perkin, Claisen, Benzoin Aldol condensations, Cannizaro reaction, Neber rearrangement and Favorskii rearrangement.

c) Free radicals: Formation, structure, stability, detection, reactions involving free radicals, addition to carbon-carbon multiple bonds.

d) Carbenes: Formation, structure, stability and reactions of carbenes. Reimer-Tiemen reaction, Wolff rearrangement. Ring expansion reactions - conversion of pyrrole to pyridine. (12h)

2. Stereochemistry : General concept of Stereoisomerism, axially dissymmetric molecules such as biphenyls and allenes. Stereochemistry of some elements other than carbon: elementary stereochemistry of Nitrogen Sulfur and Phosphorous compounds. Conformational analysis of cyclohexane, mono and disubstituted cyclohexanes, heterocycles such as tetrahydro-pyrans with special emphasis on monosaccharides, and piperidines. (08h)

3. Pericyclic Reactions: Symmetry properties of molecular orbitals. Woodward Hoffmann rules. Correlation diagram, FMO approach and PMO approach for electrocyclic reactions, cycloadditions, and sigmatropic rearrangements, Applications. (07h)

4. Organic Photochemistry: (07h)

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Light absorption. Electronic transitions, Jablonski diagram. Intersystem crossing. Photosensitization. Excited states of ketones. α Cleavage, γ - hydrogen abstraction, di-pie methane rearrangement, Paterno-Buchii reaction and Photoreduction. Photochemistry of conjugated dienes and enones.

5. Combinatorial Chemistry Introduction, solid phase and liquid phase synthesis, split, parallel, mix and split synthesis, creating molecular libraries, limitations of combinatorial synthesis. Examples of combinatorial synthesis: benzodiazepines, quinazolines, imidazoles, hydantoins. (6 Hrs)

6. Name reactions; their mechanism and applications in drug synthesis (10h) i) Witting ii) Knorr Pyrazole synthesis iii) Darzen iv) Strecker amino acid synthesis v) Meerwein Ponndorf- verley vi) Oppenauer oxidation vii) Wolf Kishner reduction viii) Mannich

7. Design of synthesis: An introduction of synthons and synthetic equivalents, general principles of the disconnection approach, functional group interconversions, the importance of order of events in organic synthesis, one group C-X and two group C-X, chemoselectivity, reversal of polarity, use of nitro compounds in organic synthesis and concept of protection and deprotection of functional groups. (10h)

Reading Material Recommended 1. Jerry March’s Advanced Organic Chemistry, Reactions, Mechanisms and Structure, 5th edition, M.B. Smith

and Jerry March, John Wiley and Sons New York, U.S.A., 2001. 2. Stereochemistry of Carbon Compounds, reprint 14th edition, Ernest L. Eliel McGraw- hill Book Company

Inc., New York, U.S.A., 1990. 3. Organic Photochemistry by William Horsepool. Reactive Intermediates by C.W. Rees. 4. S.P. Singh and S.M. Mukherji, Reaction Mechanism in Organic chemistry, The macmillian Company of India

Limited, New Delhi, India. 5. Organic Chemistry Vol-II, by I.L. Finar Chapter II and IV. Some Modern Methods of Organic Synthesis, IIIrd

edition, by W. Carruthers, 1993. 6. Chapter-1, 3 and 6. Organic Synthesis by M.B. Smith, McGraw International edition, 1994 7. Chapter 1,3,4 & 5. The Logic of Organic Synthesis by E.J. Corey and X.M. Cheng, John Wiley and Sons,

1989, Chapter 1 & 2. Principles of Organic Synthesis, R.O.C. Norman and J.M. Coxon, Chapmann and Hall, 1998.

8. Cycloadditions in Organic Synthesis by W.R Carruthers, Pergamon Press, London, 1990. 9. Classics in Total Synthesis by K.C. Nicolau and E.J. Sorensen, John Wiley, 1996.

MPH - 122: PHARMACEUTICAL CHEMISTRY – II

(ADVANCED NATURAL PRODUCTS CHEMISTRY -I) 4 Hours/Week Max. Marks - 80 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. 1. Mechanistic and biosynthetic approaches to plant secondary metabolites. Acetate-mevalonate pathway

(biosynthesis of gibberellic acid, cholesterol). (10h) 2. Shikimic acid pathway (Biosynthesis of chlorogenic acid, cichoriin). (08h) 3. Polyketides (Biosynthesis of 6-methylsalicylic acid, petulin, penicillinic acid). (08h) 4. Amino acids and peptides, nucleic acids: General introduction, synthesis, degradative and synthetic approaches

supported by spectral data of peptides and amino acids. End group analysis, structural features of Insulin, vasopressin and oxytocin, structural features of DNA & RNA. Compounds derived from Amino acids: Colchicine, Cephalosporin C. (08h)

5. Marine products with therapeutic potential in drug discovery. (06h) 6. Current developments in the discovery and design of new drug candidates from natural product leads.

(09h) 7. Lipids - Classification, role of lipids, fatty acids and glycerol derived from oils and fats; Physical

properties – polymorphism, reactions of fats, rancidity, reversion, polymerisatin, saponification, addition, hydrogenation, phospholipids, lipid metabolism, intermediary metabolism of fatty acids, synthesis of fatty acids. (05h)

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8. Vitamins - Introduction and Chemistry and biological utility of Vitamine A, E and K. Synthesis of Riboflavin, Pyridoxine, vitamin C, Niacin. (06h.

Reading Material Recommended 1. Structure Elucidation of Natural Products by Mass Spectroscopy — Vol I & II, H. Budzikiewiez,

C.Djerassic and D.H. Williams 2. Tables of Spectral Data for Structural Determination of Organic Compounds- E. Pretsch, T,Clerc, J. Seibl

and W. Simon 3. Heterocyclic Chemistry-Albert 4. Biogenesis of Natural Compounds - Bernfeld 5. An Introduction to the Chemistry of Terpenoids and Steroids-Templeton 6. Organic Chemistry of secondary Plant Metabolism-Geissman and Crout 7. Chemistry of the Alkaloids-Pelletier 8. The Chemistry of the Natural Products- Butterworths. 9. Pharmacognosy and Pharmacobiotechnology - J.E. Robbers, M.K. Speedie and V.E. Tyler. MPH - 123: PHARMACEUTICAL CHEMISTRY – III (DRUG DESIGN AND DISCOVERY)

4 Hours/Week Max. Marks – 80 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. 1. Drug receptor interactions and theories of drug action

Drug receptor interaction, G-protein coupled receptors, ion channel linked receptors. Ligand gated ion channels, voltage gated ion channels. Ligand-receptors theories: Clarks occupancy theory, rate theory, induced fit theory, macromolecular perturbation theory and activation aggregation theory. (6 Hrs)

2. Approaches to drug design Introduction, trends in lead identification, modification of lead, source of a lead: Natural products and folklore medicine, random screening, existing drugs. (2 Hrs)

3. Physicochemical and stereochemical aspects of drug action Solubility, Drug absorption, surface area and particle size, hydrogen bonding and biological activity,

polymorphism, stereochemistry and pharmacological activity. (6Hrs) 4. Recombinant DNA Technology:

Introduction, new therapeutics from r-DNA technology, protein engineering and site directed mutagenesis, genetically engineered drug discovery tools: reagents for structural biology study, enzyme as drug targets, receptors as drug targets, cellular adhesion proteins. (8 Hrs)

5. Rational Design of Enzymes Inhibitors Introduction, enzyme inhibitors in medicine and basic research.

Design of non-covalently binding enzymes inhibitors: Forces involved in enzyme-inhibitor complexes, Rapid reversible inhibitors, slow, tight and slow-tight inhibitors, transition state analogues, multisubstrate inhibitors.

Design of covalently binding enzyme inhibitors: Mechanism based inhibitors, affinity labels and pseudo-irreversible inhibitors.

Current developments with respect to the inhibition of the following enzymes: acetylcholinesterase, angiotensin converting enzyme, HMG CoA reductase, dihydrofolate reductase, GABA transferase, monoamineoxidase. (9 Hrs)

6. Analog Design Strategies of analog design: bioisosteric replacement, rigid analogs, homologation of alkyl chains, alteration in chain branching, ring size and ring position isomers, alteration in stereochemistry, fragments of lead molecules, variation in interatomic distances. (6Hrs)

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7. Quantitative structure activity relationships Fundamentals of QSAR, Quantitative description of physico-chemical properties: hydrophobicity, partition coefficient, electronic effects, steric effects. Statistical methods in QSAR, Correlation of physicochemical parameters with biological activity: Hansch approach, Free Wilson analysis, Topliss decision tree. 3D QSAR approach, Limitations of QSAR. (9 Hrs)

8. Molecular Modeling: Drawing chemical structures, conversion of 2D structures in 3D form, visualization of 3D structures, viewing proteins, geometry optimization, energy minimization procedures, molecular mechanics methods, quantum mechanics methods, molecular properties, conformational analysis, Pharmacophore concept, Pharmacophoric approach, Pharmacophore elements and representation, Pharmacophore identification, docking, homology modeling, currently used softwares for molecular modeling. (9 Hrs)

9. Prodrug Design Concept, definition and characteristics of the prodrug, Prodrugs of various functional groups, design strategies for modification of drug properties, modification of the physicochemical, pharmacokinetic and pharmacodynamic properties of a drug through chemical transformation. Applications of the prodrug approach: increased absorption, aqueous solubility, prolongation of activity, site specific chemical delivery systems, mutual prodrugs. Hard and soft drugs. (5 Hrs)

Reading Material Recommended 1. Wolff ME. Burger’s Medicinal Chemistry and Drug Discovery, Principle and Practice. John Wiley

and Sons, New York. Latest Edition. 2. Franke R. Theoretical Drug Design Methods, Vol. VII. Elsevier, New York. Latest Edition. 3. Silverman RB. The Organic Chemistry of Drug Design and Action. Academic Press Inc., San Diego,

USA. Latest Edition. 4. Kenneth M. Merz, Dagmar Ringe, Charles H. Reynolds, Drug Design: Structure and Ligand-Based

Approaches, Cambridge University Pres 5. Thomas Nogrady, Donald F. Weaver, Medicinal Chemistry: A Molecular and Biochemical

Approach, Oxford University Press 6. Alex Gringauz, “Introduction to Medicinal Chemistry” Wiley-VCH, Inc. New York. 7. Ariens, Drug Design, Academic press, NY, 1975. 8. Holtje. Sippl., Rognan and Folkers, Molecular Modeling, Wiley VCH. 9. P.K. Larsen, Tommy and U. Madsen, Textbook of Drug Design and Discovery, CRC Press. 10. T.J. Perun and C.L. Propst, Computer Aided Drug Design: Methods and Applications, Marcel

Decker. 11. Monographs and relevant review articles appearing in various periodicals and journals.

. MPH 124: PHARMACEUTICAL CHEMISTRY PRACTICAL – I 12 Hours/week Max. Marks: 120 Modern experiments having relevance to the topics covered under theory of papers MPH – 121, 122, 123 like workshops on stereochemistry, QSAR, 3D-QSAR, Pharmacophore mapping and docking studies. Synthesis of some biologically active heterocyclic nuclei such as hydantoin, thiazolidinone, imidazolidinone, indole, phenyl urea, diphenyl urea, thio-hydantoin, benzofuran, benzimidazole, thiazolidindione, etc. and their characterization. Including the followings:

1. Identification of a binary mixture by chemical (including derivative formation) and spectral techniques.

2. Determination of Ascorbic acid (Vitamin C) by UV. Spectroscopic method in crude drugs. 2. Determination of Hyoscymine/Hyoscine in Datura species by UV. Spectroscopic method. 3. Quantitative estimation of Reserpine in Rauwolfia serpentina by HPLC method.

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4. Quantitative estimation of Quinine in Cinchona bark by HPLC method. 5. Exercises on Identification of simple Naturally occurring molecules by UV, IR and NMR

spectroscopy. 6. Extraction and isolation of pectin, starch, caffeine, piperine, solanine, aromatic oils, calcium citrate,

solanine, casein, etc. 7. Synthesis and characterization of biologically active hetero-cyclic nuclei such as hydantoin, indole,

furan, benzofuran, benimidazole etc 8. Workshops based on stereochemistry, QSAR, 3D-QSAR, pharmacophore mapping and docking

studies

Second Semester MPH – 201: BIOSTATISTICS AND INTELLECTUAL PROPERTY RIGHTS 4 Hours/week Max. Marks - 80 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. Intellectual Property Rights 1. Intellectual Property Concepts and fundamentals: The emergence and growth of the concepts regarding intellectual property (IP), intellectual property protection (IPP) and intellectual property rights (IPR); economic importance, mechanism for protection of intellectual property - patents, copyright, trademarks; role of IP in pharmaceutical industry; global ramifications and financial implications. (10h) 2. Trade Related Aspects of Intellectual Property Rights Intellectual property and international trade, concept behind WTO (World Trade Organization), WIPO (World Intellectual Property Organization), GATT (General Agreement on Tariff and Trade), TRIPs (Trade Related Intellectual Property Rights),TRIMS (Trade Related Investment Measures) and GATS (General Agreement on Trades in Services), status in India and other developing countries, case studies and examples, TRIPS issues on herbal drugs. (10h) 3. Nuts and Bolts of Patenting Copyright and trade mark protection, criteria for patentability, Indian patent act. 1970: WTO and modifications under TRIPS, filing of a patent application, precautions before patenting-disclosures/non-disclosures, publication-article/ thesis, prior art search – published patents search, internet search patent sites, specialized service search requests, costs, patent application forms and guidelines, fee structure, time frames, jurisdiction aspects, types of patent application - provisional, nonprovisional, PCT and convention patent applications, international patenting requirement procedures and costs. Patent infringement: Meaning, scope, litigation, drug related patents infringements, case studies and examples, patenting by research students. Trademarks legislation and registration system in India - an introduction, meaning of trademark, criteria for eligibility, filling application for trademark registration, trade secrets - scope modalities and protection case studies. (15 h) 4. Ethics and Values in IP IP and ethics, positive and negative aspects of IPR, social responsibility, avoiding unethical practices, eco-responsibility–economic, social and environmental benefits of modern biotechnology. (5 h) Biostatistics General concepts, two-tail student t-test and paired sample t-test, two samples t-test, Wilcoxon rank-sum test, Mann-Whitney test, one-way analysis of variance, Kruskal-Wallis test, two-way analysis of variance, multiple comparison procedures in ANOVA: Fischer’s LSD test, Tukey’s studentized range test and Dunnett’s test. Non-linear regression: Introduction, iterative method. Correlation, linear regression, PCA and PLS. (20 h) Reading Material Recommended

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1. Treece DJ. Managing Intellectual Capital: Organizational, Strategic and Policy Dimension. Oxford University Press, England. Latest Edition.

2. Wadedhra BL. Law Relating to Patents, Trademarks, Copyright Design and Geographical Indications. Universal Law Publishing, New Delhi. Latest Edition.

3. Bansal P. IPR Handbook for Pharma Students and Researchers, Pharma Book Syndicate, Hyderabad. Latest Edition.

4. Copyright Protection in India [website: http:copyright.gov.in]. 5. Information on Orange Book [website: www.fda.gov/cder/ob/default.htm]. 6. World Trade Organization [website: www.wto.org]. 7. Trivedi PR. Encylcopedia of Intellectual Property Rights. Jnanada Prakashan, New Delhi. Latest Edition. 8. Arya P. P. and Yashpal, Research Methodology in Management, Deep and Deep publications Private

Limited, New Delhi. 9. Green and Tull : A research for marketing research decisions, PHI (P) Ltd. New Delhi. 10. Karishna Swami, Shiva Kumar & Mathirajan, Management Research Methodology, Pearson Education. 11. Hooda, R P, Statistics for Business and Economics, MacMillan India Limited, New Delhi. 12. Heinz, Kohler: Statistics for business and Economics, Harper Collins. 13. Lawrence B Morse: Statistics for business and economics, Harper Collins. 14. Levin, Richard I. & David S Rubin: Statistics for management PHI Delhi. MPH - 221: PHARMACEUTICAL CHEMISTRY – IV

ADVANCED SPECTRAL AND ANALYTICAL TECHNIQUES 4 Hours/week Max. Marks - 80 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. Introduction to IR, UV, NMR and MASS spectroscopy is covered in Ist Semester. 1. Infrared Spectroscopy The Hook’s law and calculation of stretching frequencies for different types of bonds and their bond strengths, coupled interactions, hydrogen bonding, examination of infrared spectrum, survey of important functional groups with examples, radiation source, detectors used, sample handling, quantitative applications, qualitative applications with special reference to stereochemical aspects and hydrogen bonding, Near-IR spectroscopy, absorption and reflectance spectrophotometry, instrumentation, applications, Far Infrared spectroscopy. Introduction to FTIR and its applications. Raman Spectroscopy - Introduction, theory and polarization measurement, rules of selection and polarization, instrumentation, applications in pharmaceutical sciences. Comparison of Infrared and Raman spectra. (9 Hrs) 2. Ultraviolet / Visible Spectroscopy and Fluorimetry Energy level and selection rules, effect of substituents, effect of conjugation, conformation and geometry, the Woodward-Fisher rules, the Fisher-Kuhn rules, applications of UV with reference to different electronic systems. Derivative spectroscopy and its applications. Fluorescence and chemical structure, fluorescence intensity, factors affecting fluorescence, instrumentation, comparison of fluorometry with spectrophotometry, applications of fluorimetry in pharmaceutical analysis. (7 Hrs) 3. Nuclear Magnetic Resonance Spectroscopy 1H-NMR spectroscopy Magnetic equivalence, failure of the N+1 rule, chemical shifts, local diamagnetic shielding, hybridization effects, magnetic anisotropy, mechanism of spin-spin coupling, the origin of spin-spin splitting, Pascal’s triangle, the coupling constant, protons on oxygen, nitrogen and sulphur, diastereomeric protons, chemical shift reagents, long range coupling, spin decoupling methods, nuclear over Hauser effect. Correlation NMR spectrometry: introduction to 1H -1H cosy and 1H - 13C cosy and its applications. Introduction and applications of 2D NMR; solid state NMR. 13C-NMR spectroscopy Introduction, peak assignments, off resonance decoupling, selective proton decoupling; chemical shift equivalence; chemical shifts; spin coupling. Spectrometry of other important nuclei - Introduction to 15N, 19F, 31P, basic concepts. (11 Hrs) 4. Mass Spectrometry

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Basic principle and theory involved; instrumentation, type of ions; various ion sources, electron impact source, chemical ionization sources, field ionization sources, desorption sources, mass analysers, double focusing, quadripole, time of flight, ion trap analyzer, ionization, fragmentation, rearrangements, mass spectra of representative compounds, recognition of molecular ion peak, metastable peak, isotopic peaks, applications. (10 Hrs) 5. X-Ray Spectroscopy Introduction, production and properties of the X-ray, X-ray emission, X-ray absorption, principles of X-ray diffraction, powder diffraction, X-ray diffraction methods, application of X-ray diffraction technique in pharmaceutical sciences. Electron microscopy and electron diffraction. (6 Hrs) 6. Chromatography

a. Gas Chromatography: Gas liquid chromatography, gas solid chromatography, instrumentation and applications (GC-MS and GC-FTIR). Derivatization as a means of sampling of thermosensitive compounds.

b. High Pressure Liquid Chromatography: Partition, adsorption, ion exchange, size exclusion; pharmaceutical applications of HPLC and LC-MS. Super critical fluid chromatography; brief introduction to HPTLC. (9 Hrs)

7 Electrophoresis: Theory and application of electrophoresis, polyacrylamide and agarose gel electrophoresis, capillary electrophoresis, 2- D electrophoresis. (8 Hrs)

Reading Material Recommended 1. Silverstein RM and Webster FX. Spectrometric Identification of Organic Compounds. John Wiley

and Sons, New York. Latest Edition. 2. Chatten LG. Pharmaceutical Chemistry, Vol I & II. Marcel Dekker, New York. Latest Edition. 3. James WD and Kenneth HT. Analytical Chemistry by Open Learning: Thermal Methods. John wiley

and Sons, New York. Latest Edition. 4. Abraham RJ, Fisher J and Bftus P. Introduction to NMR Spectroscopy. John Wiley and Sons, New

York. Latest Edition. 5. Pavia DL, Lampman GM and Kriz GS. Introduction to Spectroscopy. Harcourt College Publishers,

Orlando. Latest Edition. 6. UV and Visible Spectroscopy, Chemical Application-C.N. R. Rao. 7. Spectrometric identification of organic compound- Silverstein. 8. Spectrometric identification of organic compound- William Kemp 9. Chemical application of IR spectroscopy - C.N.R. Rao. 10. Interpretation of Mass Spectra of organic compounds-B. Kienicz, C. Djerassi. 11. Application of NMR Spectra to Organic Chemistry-Jackmann. 12. Instrumental Methods of Analysis- Willard. 13. Applications of Absorption spectroscopy of organic compounds - John R. Dyer. 14. Kasture, A.V. Mahadik, K.R. Wadodkar , S.G. and More, H.N. (2004). Pharmaceutical analysis Vol-

II Instrumental methods. Nirali Prakashan. MPH - 222: PHARMACEUTICAL CHEMISTRY – V

ADVANCED MEDICINAL CHEMISTRY - II 4 Hours/week Max. Marks - 80 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. 1. Antibacterial agents

Introduction, history and development of resistance to known antibacterials such as penicillins. Bacterial DNA-gyrase inhibitors - mode of action of fluoro-quinolones and development of newer analogues: Trovafloxacin, Levofloxacin, Gratifloxacin including Ciprofloxacin and Norfloxacin, Oxazolidinones: Inhibitors of DNA Synthesis. (7hrs)

2. Anti-cancer drugs Newer targets for anticancer therapy, Topoisomerase inihibitors: Histonedeacetylase inihibitors, Telomerase Inhibitors. Tumor helicases inhibitors: Antimitotic agents. Tubulin interacting agents: DNA-intercalators: DNA-threading agents: Tumor necrosis factor converting enzyme (TACE) inhibitors. Anti cancer drugs for crossing BBB. (7hrs)

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3. Drugs affecting Adrenergic neurotransmission: Introduction, history and neurotransmission at sympathetic nervous system; biosynthesis and metabolism of NE; characterization of adrenergic receptor subtypes and mechanism. Structure activity relationship of adrenergic agonists and antagonists. (7hrs)

4. Cardiovascular drugs: a. Anti-hypertensives: Designing of ACE & AT1 inhibitors – Captopril, Enalapril, Enalprilat, Lisinpril,

Losartan. b. β-blockers, α-blockers and α,β-blockers – Atenolol, Metprolol and analogues, Carvedilol, Prazocin,

Trazocin, Labetelol c. Calcium Channel blockers: 1,4-dihydropyridines (Nifedipine, Nimodipine, Nicardipine), Verapamil,

Diltiazem. d. Lipid lowering and anti-clotting agents – Statins eg., Atorvastatin, Rosuvastatin; Aspirin, Lipitor,

Gemfibriogel, abciximab, Probucol, Celcade, clopidgrel. e. Selective human β3 adrenergic agonists used as antiobesity agents. f. Clot busters: Urokinase, Streptokinase, Alfimeprase. g. Anti – arrhythmic agents: Amidorane, Digoxin, Flecainide, Mexiletine, Tocainide, Lidocaine. h. Peptides with cardiovascular applications. (12Hrs)

5. Antiviral Agents DNA and RNA viruses, retroviruses, strategies to design anti-HIV drugs, viral replication, anti-viral agents for RNA-virus infections, development of new drugs and drug discovery Diadanosine, Nevirapine. (7Hrs)

6. Psychopharmacological Agents Psychopharmacological agents : Antipsychotic Agents : Biochemical basis of mental disorders, Development of antipsychotic agents, tricyclic antidepressants, Monoamine oxidase inhibitors; Selective serotonin-reuptake inhibitors; Atypical antidepressants, Antianxiety Agents : Chemistry of benzodiazepines; SAR of benzodiazepine derivatives, medicinal chemistry of non-benzodiazepines; serotonin-reuptake inhibitors, development of meprobamate and analogues; atypical anxiolytic agents; including studies of various receptors - GABA, Dopamine, NMDA, Metabotropic glutamate, excitatory amino acid neurotransmitters (7 Hrs)

7. Drugs affecting hormonal system: Adrenocorticoids, estrogen, progestins and androgens. Chemical contraceptives; latest advances in drug receptors chemistry. (8 Hrs)

8. Prostaglandins and Other Eicosanoids -Nomenclature, biosynthesis, design of eicosanoid drugs, biological activity, metabolism, structure activity relationship, eicosanoids approved for human clinical use. (5 Hrs)

Reading Material Recommended 1. Wolff ME. Burger’s Medicinal Chemistry and Drug Discovery, Principle and Practice. John Wiley

and Sons, New York. Latest Edition. 2. Alnley W and James EF. Martindale, The Extra Pharmacopoeia. Pharmaceutical Press,London.

Latest Edition. 3. Nogrady T. Medicinal Chemistry, A Biochemical Approach. Oxford University Press,New York.

Latest Edition. 4. Monographs and relevant review articles appearing in various periodicals and journals. 5. Franke R. Theoretical Drug Design Methods, Vol.VII. Elsevier, New York. LatestEdition. 6. C. H. Wermuth, “The Practice of Medicinal Chemistry”, Academic Press, London, 1969, 264. 7. The Quinolones, 2nd edition, edited by V.T. Andriole. Academic Press, 1998 8. Cancer Chemotherapeutic Agents. Edited by W.O. Foye, American Chemical Society, 1995. 9. Introduction to the Principles of Drug Design and Drug Action, Edited by H.J. Smith, Taylor and

Francis, 2006. 10. Manfred E Wolff, (ed), Burger’s Medicinal Chemistry and Drug Discovery, Vol – I Principles and

Practice, 5th Ed., Join Wiley and Sons, 1995. 11. J. G Vinter and Mark Gardner, (Eds.) Molecular Modelling and Drug Design, The Macmillan Press

Ltd., London, U.K., 1994. 12. C. Hansch, A. Leo and D. Heokman, Exploring QSAR: Applications in Chemistry and Biology, ACS

Professional Reference Book, American Chemical Society, Washington U.S.A., 1995.

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13. Comprehensive Medicinal Chemistry, Pcrgamon press, 1990, Vol. 4. · Medicinal Chemistry for the 21st Century, Edited by C.G. Wermuth, Blackwell Scientific Publications, Oxford, 1992.

14. Pseudopeptides in Drug Discovery, Edited by P.E. Nielson, Wiley-VCH, 2004 15. Introduction to the Principles of Drug Design and Drug Action, Edited by H.J. Smith, Taylor and

Francis, 2006. 16. The Organic Chemistry of Drug Design and Drug Action, 2nd edition, R.B.Silverman, Academic

Press, 2006. 17. Molecular Modeling in Drug Design, Edited by N.C. Cohen, Elsevier, 2006

MPH - 223: PHARMACEUTICAL CHEMISTRY – VI

ADVANCED NATURAL PRODUCTS CHEMISTRY - II 4 Hours/week Max. Marks – 80 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. 1. General introduction and classification, isolation and purification methods of alkaloids, structure

elucidation of reserpine, atroipine and morphine. (12 h) 2. Classification, method of isolation, chemistry, degradation, synthetic methods, spectral techniques for

structural elucidation and biological activity of flavonoids rutin and quercetin. (12 h)

3. Study of chemistry, stereochemical aspects and pharmaceutical importance of plant derived steroids -cardiac glycosides (cholesterol, diosgenin). (07 h)

4. Recent advances in the chemistry of naturally occurring anti-neoplastic agents (catharanthus alkaloids, camptothecin); antimalarials (cinchona alkaloids, artemisinin derivatives). (10 h)

5. General introduction and classification terpenoids; Essential Oils; Production of Essential Oils ; Chemistry and Analysis of Essential Oils ; Biological Activities of Essential Oils ; Aromatherapy with Essential Oils ; Industrial Uses of Essential Oils, Essential Oils Used in Veterinary Medicine; Trade of Essential Oils; Recent EU Legislation on Flavors and Fragrances of Essential Oils (15 hrs)

6. Role of natural products in “Neglected Diseases” (dengue, protozoal diseases including leishmaniasis, trypanosomiasis, schistosomiasis, tuberculosis, leprosy). (4 h)

Reading Material Recommended 1. Cordell GA. Introduction to Alkaloids. John Wiley and Sons, New York. Latest Edition. 2. Fieser LF and Fieser M. Steroids. Reinhold Publishing Co., New York. Latest Edition. 3. Wickery ML and Wickery B. Secondary Plant Metabolism. Mcmillan Press Ltd. London. Latest

Edition. 4. Torseel KBG. Natural Product Chemistry. John Wiley and Sons, New York. Latest Edition. 5. Harborne JB. Phytochemical Methods. Chapman and Hall, London. Latest Edition. 6. Finar IL. Organic Chemistry. The English Language Book Society, London. Latest Edition. 7. Wolff ME. Burger’s Medicinal Chemistry and Drug Discovery, Principle and Practice. John Wiley and

Sons, New York. Latest Edition. 8. Mitscher LA and Baker WR. A Search for Novel Chemotherapy Against Tuberculosis Amongst

Natural Products. Pure and Applied Chemistry (1998) , Vol. 70, No.2, pp 365-371. 9. Wermuth CG. The Practice of Medicinal Chemistry. Academic Press, Jordon Hill, Oxford. Latest

Edition. 10. Boldi AM. Combinatorial Synthesis of Natural Product Based Libraries. Taylor and Francis, London.

Latest Edition. 11.Monographs and relevant review articles appearing in various periodicals and journ

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MPH – 224: PHARMACEUTICAL CHEMISTRY PRACTICAL – II 12 Hours/week Max. Marks – 120 Multi-step Synthesis of Organic Medicinal Compounds, their intermediates, chromatographic purification and spectroscopic characterization including that of sulfanilamide, para-aminobenzoic acid, anti-pyrine, benzocaine, methaqualone, phenytoin, uramil, saccharine, chloramine-T, dichloramine-T, etc, including the followings:

1. Simultaneous estimation of Paracetamol and Ibuprofen: Aspirin and Caffeine ; Rifampicin and Isoniazid or other combination formulation (4 expts).

2. UV. Visible spectrum scanning of certain organic cornpounds – absorption and correlation of structures and comparison e.g., Chloramphenicol, Analgin, Sulphadiazine, Ibuprofen

3. Exercises on interpretation of at least 5-different known compounds of Natural origin by using spectroscopic data (NMR & MASS)

4. Workshop on spectroscopy structural elucidation of at least 5 unknown compounds. 5. IR, NMR & Mass spectroscopy (1 compound each). 6. Effect of pH and solvent On U.V. Spectrum of certain drugs. 7. Multi-step Synthesis of Organic Medicinal Compounds and intermediates, their chromatographic

purification and spectroscopic characterization including sulphanilamide, PABA, benzocaine, antipyrine, phenytoin, methaqualone and chloramine T etc.

8. Practicals based on extraction and isolation of natural products using Hot continous soxhalation, preparative TLC, HPTLC.

7. Paper reading/seminar with respect to the latest developments in pharmaceutical chemistry, writing of papers, projects and reports. Skills in oral presentation/presenting research papers.

8. Exercise on interpretation of known natural products by using spectroscopic data (NMR & MASS). Reading Material Recommended

1. F.C. Mann and B.C. Saunders, Practical Organic Chemistry, orient Longman, 4th edition, New Delhi, India 1960

2. A.I. Vogal, A Text Book of Practical Organic Chemistry, 5th edition, The English Language Book Society and Longman Group Limited London, U.K. 1991.

3. R.M. Silverstein, G.C. Bassler and T.C. Morrill, Spectrometric Identificaion of Organic Compounds, 5th edition, John Wiley and sons, Inc., New York, U.S.A., 1991

4. E.L. Eliel, Sterochemistry of Carbon Compunds, Reprint 14th edition, Mc GrawHill Book Company, Inc., New York, U.S.A. 1990.

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INSTITUTE OF PHARMACEUTICAL SCIENCES, KURUKSHETRA UNIVERSITY KURUKSHETRA

Syllabus: M. Pharm. (Pharmaceutical Management) First Semester

Paper – I

MPH - 101: MODERN PHARMACEUTICAL AND ANALYTICAL TECHNIQUES 4 hours/week Max. Marks 80 Note: The paper setter will set 7 questions (First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus; three question from section A and one question from each section B, C and D); out of which the candidate will be required to attempt 5 questions in all and atleast one question from each section. All questions will carry equal marks. A. Pharmaceutical Chemistry (27h)

1. Infrared Spectroscopy (4h) Introduction, the infrared absorption process, the modes of vibrations, stretching and bending, bond properties and absorption trends, basics of instrumentation techniques, pharmaceutical applications.

2. Ultraviolet Spectroscopy (3h) Introduction, the nature of electronic excitation, the origin of uv band structure, principle of absorption spectroscopy, chromophore- σ→σ*, η→σ*, π→π* transitions, basics of instrumentation techniques, pharmaceutical applications.

3. Nuclear Magnetic Resonance Spectroscopy (4h) Introduction, nuclear spin states, nuclear magnetic moments, absorption of energy, the mechanism of resonance, chemical equivalence, spin-spin coupling, basics of instrumentation techniques, pharmaceutical applications.

4. Mass Spectrometry (5h) Basic principle and theory involved, basics of instrumentation techniques, pharmaceutical applications.

5. Thermal Analysis (7h) Introduction to various thermal methods of analysis, basic principles and theory, instrumentation and pharmaceutical applications of thermo gravimetric analysis (TGA), differential thermal analysis (DTA), differential scanning calorimetry (DSC) and microcalorimetry, different types of calorimeters and micro calorimeters, advantages of microcalorimetry over DSC.

6. Optical Rotatory Dispersion and Circular Dichroism (4h) Definition, theory and instrumentaton of ORD and CD. Cotton effect, Octant rule and its

applications B. Pharmaceutics (13h)

1. Basic elements of Novel drug delivery systems. 2. Bioavailability and bioequivalence testing, significance of terminology, conduct of bioavailability

trials. 3. Introduction to validation of manufacturing facilities I.Q. / O.Q. and certification,

preparation of validation protocols. 4. Stability testing: Stress testing of drug substances, stability testing protocols, shelflife

determination, ICH guidelines. C. Pharmacognosy (10h)

Plant tissue culture: Conventional breeding v/s tissue culture, Applications of Plant tissue culture technique,Tissue culture media (composition & preparation), Preparation of explant, Sterilization techniques, Type of cultures, Protoplast technology and its applications, Immobilization techniques and their applications, Tissue culture as a technique to produce novel plants and hybrids, Factors affecting the production of secondary metabolites from tissue- culture.

D. Pharmacology (10h) Definition of bioassay, various types of bioassays, advantages and limitations of bioassays with suitable examples, Theory and application of radioimmunoassay and ELISA. Animal models for screening of anti-inflammatory, anti-convulsant, and anti-diabetic.

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Reading Material Recommended 1. Silverstein RM and Webster FX. Spectrometric Identification of Organic Compounds. John Wiley and

Sons, New York. Latest Edition. 2. Pavia DL, Lampman GM and Kriz GS. Introduction to Spectroscopy. Harcourt College Publishers,

Orlando. Latest Edition. 3. Vogel HG and Vogel WH. Drug Discovery and Evaluation. Springer-Verlag, Berlin. Latest Edition. 4. Kulkarni SK. Handbook of Experimental Pharmacology. Vallabh Prakashan, New Delhi. Latest

Edition. 5. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata. Latest

Edition. MPH 102: MODERN PHARMACEUTICAL AND ANALYTICAL TECHNIQUES PRACTICAL 4 Hours/week Max. Marks: 80

Modern experiments having relevance to the topics covered under theory.

Reading Material Recommended 1. Indian Pharmacopoeia, Central Indian Pharmacopoeia Laboratory, Govt. of India, Ministry of Health

& Family Welfare, Ghaziabad, Latest Edition. 2. U. S. Pharmacopoeia – NF, The United States Pharmacopoeial Convention, Rockville, USA, Latest

Edition. 3. European Pharmacopoeia, Directorate for the Quality of Medicines of the Council of Europe

(EDQM), Strasbourg, Europe, Latest Edition. 4. British Pharmacopoeia, The Stationary Office on behalf of the Medicine Health Care Product

Regulatory Agency (MHRA), London, Latest Edition. 5. Mendham J, Denney RC, Barnes JD and Thomas M. Vogel’s Textbook of Quantitative Chemical

Analysis. Pearson Education Limited, Singapore. Latest Edition. 6. Silverstein RM and Webster FX. Spectrometric Identification of Organic Compounds. John Wiley and

Sons, New York. Latest Edition. 7. Vogel HG and Vogel WH. Drug Discovery and Evaluation. Springer-Verlag, Berlin. Latest Edition. 8.

Kulkarni SK. Handbook of Experimental Pharmacology. Vallabh Prakashan, New Delhi. Latest Edition.

9. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata. Latest Edition.

Paper (MPH 151): Management Concepts and Organisational Behaviour 4 Hours/week Max. Marks - 60 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. Course Objective: The objective of this course is to develop an understanding of functions of management and the concepts, theories and techniques in the field of organizational behaviour. Course Contents: Management meaning nature and significance; Approaches to management, functions of a manager, planning: nature type and significance of planning, planning process; Management by objectives- process, benefits and limitations. Organisation: meaning, nature and importance, principles of organization, different forms of organization structure; form of different business organizations (corporate & non corporate); Departmentation- meaning and various bases of departmentation. Centralisation and Decentralization. Staffing: meaning, objectives and process of staffing.

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Leadership:- Meaning, style and theories of leadership; Motivation- meaning, importance and theories of motivation, tools of Motivation Communication- Concept, importance and process of Communication, types of communication, barriers to communication, developing effective communication. Organizational Culture & Control- meaning, characteristics, process of control, control techniques and concept, importance and components of culture. Quality of work life. Organisational Conflict - meaning, features and types of conflict, conflict resolution. Organisational change- meaning and nature of work change, resistance to change, management of change. Organisational development-concept,pre-requisites and steps in organizational development. Recommended Readings: 1) Sekaran,Uma: Organisational Behaviour-Text& Cases ; Tata McGraw Hill(Indian Edition 2) Newstorm: Organisational Behaviour; Tata McGraw Hill(Indian Edition) 3) StevenL Mcshane, M.A.V. Glinow and R.R. Sharma : Organisational Behaviour; Tata McGraw Hill(Indian Edition) 4) S. Robbins , Organisational Behaviour, Prentice Hall Of India. Paper (MPH 152): Pharmaceutical Marketing Management 4 Hours/week Max. Marks - 60 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. Course Objective: The course aim is to provide and understanding of marketing concepts and techniques and the application of the same in the pharmaceutical industry Course Contents Marketing : Meaning, concepts, importance and emerging trends; Marketing environment; Industry and competitive analysis, Indian Pharmaceutical Industry; Analysing consumer buying behaviour; industrial buying behaviour, Pharmaceutical market segmentation & targeting. Product Decision- Meaning, Classification, product line and product mix decisions, product life cycle, product portfolio analysis; product positioning; New product decisions; Product branding, packaging and labeling decisions, Product management in pharmaceutical industry. Pricing- Meaning, importance, objectives,determinants of price; pricing methods and strategies, issues in price management in pharmaceutical industry.An overview of DPCO(Drug Price Control Order)and NPPA(National Pharmaceutical Pricing Authority). Pharmaceutical marketing channels: Designing channel, channel members, selecting the appropriate channel, conflict in channels, physical distribution management: Strategic importance, tasks in physical distribution management. Promotion- meaning and methods, determinants of promotional mix, promotional budget; an overview - personal selling, advertising, sales promotion and public relations. Product – concept and classification of products ; product management decisions ; product mix decisions ; role of product manager ; organizing for new product development, strategic alliances for new product development, new product development process, financial analysis for product development. Environmental analysis ; identifying competitive set ; competitor analysis – sources of information and process ; category attractiveness analysis – product life cycle, product portfolio approach and matrix approach ; customer analysis ; estimating market potential and sales forecasting ; product positioning ; product strategies; financial analysis for product development ; test marketing and new product launch. Strategic marketing planning; Marketing implementation and evaluation. Recommended Readings: 1) Philip Kotler and Kevin Lane Keller: Marketing Management, Prentice Hall of India, New Delhi 2) Walker, Boyd and Larreche : Marketing Strategy- Planning and Implementation, Tata MC Graw

Hill, New Delhi. 3) Dhruv Grewal and Michael Levy: Marketing, Tata MC Graw Hill 4) Arun Kumar and N Menakshi: Marketing Management, Vikas Publishing, India

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5) Rajan Saxena: Marketing Management; Tata MC Graw-Hill (India Edition) 6) Ramaswamy, U.S & Nanakamari, S: Marketing Managemnt:Global Perspective, Indian

Context,Macmilan India, New Delhi. 7) Shanker, Ravi: Service Marketing, Excell Books, New Delhi 8) Subba Rao Changanti, Pharmaceutical Marketing in India (GIFT – Excel series) Excel Publications. Paper (MPH – 153): Accounting and Financial Management 4 Hours/week Max. Marks - 60 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. Course Objective: The course aim is to provide an understanding of relevant accounting concepts and techniques in order to facilitate managerial decision making. Course Contents Accounting: VI of Companies Act, 1956; Depreciation Accounting & Policy; measurement of Income; preparing of cash flow Meaning, Nature and role of accounting, Accounting equation; accounting concepts and conventions; Accounting records & processes; Drafting of Profit and Loss account and Balance Sheet of non-corporate Performa of Schedule statement entities; Cost: concept, nature, elements and classification; Cost sheet.Types of costing: An overview of job costing, process costing and contract costing . Marginal costing; cost-volume profit analysis and its business applications. Budgetary Control: Concept & types of budgets, flexible budgeting, concept of zero based budgeting; Standard costing & elementary material and labour variance Analysis; Responsibility accounting; An overview of Management control techniques. Financial Management: Meaning and objectives, Financial decisions, status and duties of finance executives, time value of money. Introduction to working capital management;. Financial analysis:meaning, importance and tools (an overview). Recommended Readings:

1. Pandey I.M, Management Accounting, Vikas Publishing House, Delhi. 2. Pandey I.M, Financial Management, Vikas Publishing House, Delhi. 3. Chandra, Prasana, Financial Management, Tata McGraw Hill, Delhi. 4. Khan and jain, Financial Management, Tata McGraw Hill, Delhi.

PAPER (MPH – 154): Managerial Economics 4 Hours/week Max. Marks - 60 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. Course Objective: The course aims at developing an understanding of various concepts, theories and techniques of managerial economics that contribute to business decision making. Course Contents Managerial Economics: Nature and scope, managerial economist’s role and responsibilities,An Overview -objectives of firm; Decision rules /principles. Demand Analysis: Law of demand, determinants of demand; Elasticity of demand – Meaning; Price elasticity, income elasticity and cross elasticity, using elasticity in managerial decisions. Demand forecasting. Production Theory: Production function – Production with one and two variable inputs; Law of variable proportions; Law of returns to scale; Stages of production; Economies of Scale; Cost Theory:cost concepts, Short and long run costs– their nature, shape and inter – relationship ;Theory of consumer Choice: Cardinal utility approach, ordinary utility approach, Revealed preference theory.

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Price Determination Under Different Market Conditions: Characteristics of different market structures; Price determination and firm’s equilibrium under perfect competition, monopolistic competition, oligopoly and monopoly. Pricing Practices: Methods of price determination in practice; Pricing of multiple products; Price discrimination and dumping; Transfer pricing. Business Cycles: Nature and phases of a business cycle. Inflation: Definition, characteristics and types; causes and effects of inflation; An overview of basic concepts – National Income, Monetary policy; Fiscal policy. Recommended Readings:

(i) Dwivedi DN, Managerial Economics, Vikas Publishing House (ii) Ahuja HL, Advanced Economic Theory, S.Chand & Sons (iii) Ahuja HL, Business Economics, S.Chand & Sons (iv) Chopra PN, Managerial Economics, Kalyani Publishers. (v) Adhikari M., Managerial Economics, Excel Books. (vi) Peterson H. & W. Chris Lewis, Managerial Economic Analysis and Cases, Pearson Education.

MPH – 155: SOFT SKILL DEVELOPMENT 2 Hours/week ---------------- Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. Course Objective: The course aims at developing an understanding of various concepts concerning communication and grooming the personality of candidates by developing soft skills in them. Course Contents: Business Communication: Meaning, Basic forms of communication,Communication process, Theories of Communication; Self – Development andCommunication; Body Language: meaning, importance and gestures. Strategic human resource management – concepts, process and importance ; Human resource planning – nature, importance, process and prerequisites ; Job Analysis – concept, purpose, process and problems ; Recruitment – process, policy, methods ; Selection – concept and process ; Work force adjustment and right sizing – promotion, transfer and separation, voluntary retirement schemes ; Training and development – definition and significance, training principles, process, methods ; Career planning and development – career stages, career planning process, career development process, problems ; Performance appraisal – nature, issues and methods ; Counseling – meaning, role and forms ; Job evaluation – concept, process and methods ; Compensation – significance, components and factors affecting compensation, devising compensation plan ; Incentives and fringe benefits – an introduction ; Stress Management – meaning, sources of stress, coping strategies for stress ; Quality of work life Effective Listening: Principles of effective listening; Factors affecting listening exercise. Group Discussion; Mock interviews; Interview skills: Appearing in interviews; Writing resume and letter of application. Seminars: Oral presentation, principles of oral presentation, factors affectingpresentation. Report writing and its contents evaluation through copyright softwares. Modern forms of communication: Fax, E-mail, Video conferencing, etc. Suggested Readings: Suggested Readings: 1. Bovee and Thill: Business Communication Today, Tata McGraw Hill, New Delhi. 2. Ronald E. Dulek and John S. Fielder: Principles of Business Communication; Macmillan Publishing

Company, London 3. Balasubramanyam: Business Communications; Vikas Publishing House, Delhi. 5. Kaul: Business Communication; Prentice Hall, New Delhi. K. Aswathappa: Human Resource

Management(Text & Cases), Tata Mc Graw Hill, N. Delhi. 6.John M Ivancevich: Human Resource Management, Tata Mc Graw Hill (Indian Edition).

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7.Biswajeet pattanayak: Human Resource Management, Prentice Hall, India. 8.Snell and Bohlander: Human Resource Management, Thomson South-western(Indian Edition). MPH – 155: SOFT SKILL DEVELOPMENT PRACTICAL 2 Hours/week ---------------- Practical training on soft skill development. Second Semester MPH – 201: BIOSTATISTICS AND INTELLECTUAL PROPERTY RIGHTS 4 Hours/week Max. Marks - 80 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. Intellectual Property Rights 1. Intellectual Property Concepts and fundamentals: The emergence and growth of the concepts regarding intellectual

property (IP), intellectual property protection (IPP) and intellectual property rights (IPR); economic importance, mechanism for protection of intellectual property - patents, copyright, trademarks; role of IP in pharmaceutical industry; global ramifications and financial implications. (10h)

2. Trade Related Aspects of Intellectual Property Rights Intellectual property and international trade, concept behind WTO (World Trade Organization),

WIPO (World Intellectual Property Organization), GATT (General Agreement on Tariff and Trade), TRIPs (Trade Related Intellectual Property Rights),TRIMS (Trade Related Investment Measures) and GATS (General Agreement on Trades in Services), status in India and other developing countries, case studies and examples, TRIPS issues on herbal drugs. (10h)

3. Nuts and Bolts of Patenting Copyright and trade mark protection, criteria for patentability, Indian patent act. 1970: WTO and

modifications under TRIPS, filing of a patent application, precautions before patenting-disclosures/non-disclosures, publication-article/ thesis, prior art search – published patents search, internet search patent sites, specialized service search requests, costs, patent application forms and guidelines, fee structure, time frames, jurisdiction aspects, types of patent application - provisional, nonprovisional, PCT and convention patent applications, international patenting requirement procedures and costs. Patent infringement: Meaning, scope, litigation, drug related patents infringements, case studies and examples, patenting by research students. Trademarks legislation and registration system in India - an introduction, meaning of trademark, criteria for eligibility, filling application for trademark registration, trade secrets - scope modalities and protection case studies. (15 h)

4. Ethics and Values in IP IP and ethics, positive and negative aspects of IPR, social responsibility, avoiding unethical practices,

eco-responsibility–economic, social and environmental benefits of modern biotechnology. (5 h) Biostatistics

General concepts, two-tail student t-test and paired sample t-test, two samples t-test, Wilcoxon rank-sum test, Mann-Whitney test, one-way analysis of variance, Kruskal-Wallis test, two-way analysis of variance, multiple comparison procedures in ANOVA: Fischer’s LSD test, Tukey’s studentized range test and Dunnett’s test. Non-linear regression: Introduction, iterative method. Correlation, linear regression, PCA and PLS. (20 h)

Reading Material Recommended 1. Treece DJ. Managing Intellectual Capital: Organizational, Strategic and Policy Dimension. Oxford

University Press, England. Latest Edition.

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2. Wadedhra BL. Law Relating to Patents, Trademarks, Copyright Design and Geographical Indications. Universal Law Publishing, New Delhi. Latest Edition.

3. Bansal P. IPR Handbook for Pharma Students and Researchers, Pharma Book Syndicate, Hyderabad. Latest Edition.

4. Copyright Protection in India [website: http:copyright.gov.in]. 5. Information on Orange Book [website: www.fda.gov/cder/ob/default.htm]. 6. World Trade Organization [website: www.wto.org]. 7. Trivedi PR. Encylcopedia of Intellectual Property Rights. Jnanada Prakashan, New Delhi. Latest

Edition. 8. Arya P. P. and Yashpal, Research Methodology in Management, Deep and Deep publications Private

Limited, New Delhi. 9. Green and Tull : A research for marketing research decisions, PHI (P) Ltd. New Delhi. 10. Karishna Swami, Shiva Kumar & Mathirajan, Management Research Methodology, Pearson

Education. 11. Hooda, R P, Statistics for Business and Economics, MacMillan India Limited, New Delhi. 12. Heinz, Kohler: Statistics for business and Economics, Harper Collins. 13. Lawrence B Morse: Statistics for business and economics, Harper Collins. 14. Levin, Richard I. & David S Rubin: Statistics for management PHI Delhi. MPH-251: INTERNATIONAL BUSINESS MANAGEMENT

4 Hours/week Max. Marks - 60 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. Course Objective: The course aim is to provide insights into the emerging developments in International business environment and the management of international business operations. Course Contents: International business - meaning and modes of International business ; Globalization – concepts, characteristics and drivers ; International business environment – cultural, economic, political and legal environment ; World Trade Organizations (WTO) – structure and overview of agreements ; Regional economic groupings – meaning, levels and implications for International business ; Foreign Direct Investments (FDI’s) – concepts, types, motives, impact of FDI, Foreign Direct Investment in India ; Multinational Enterprises(MNEs) – features, types, factors affecting MNEs ; Foreign market entry strategies and strategic alliances – basic entry decisions, entry modes selection, reasons and process of strategic alliance management. Export-Import policy in India – salient features ; International commercial terms (Incoterms) ; Import-Export documentation - Bill of Exchange, Marine Insurance policy, Invoices and other documents ; Transport documents - Bill of lading, Airway Bill, Multimodal transport documents ; Letter of Credit – meaning, types of letter of credit ; Financing exports - preshipment credit, post-shipment finance ; Financing imports ; Export credit Insurance – standard and specific policies, guarantees. Suggested Readings:

1. Sundram and Black : International business environment, Prentice Hall of India. 2. Daniels and Radebough : International Business, Pearson Education. 3. Charles WL Hill : International business, Tata Mc Graw Hill, N.Delhi. 4. Arun Kumar Jain : Competing in the Global market place, Tata Mc Graw Hill N.Delhi. 5. Francis Cherunilam ; International business, Prentice Hall of India. 6. Sunil Gupta : International Marketing, Kalyani Publishers N.Delhi. 7. Rao M.B, Manjula: WTO and International Trade, Vikas Publishing

House, N.Delhi.

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8. Aswathappa : International Business, Third Edition, Tata McGraw Hill, N.Delhi. 9. Rai, Usha Kiran : Export-Import and Logistics Management, Prentice Hall of India, N.Delhi.

10. Kapoor, D.C : Export Management, Vikas Publishing House.

MPH-252: PRODUCTION, MATERIALS AND PRODUCT MANAGEMENT 4 Hours/week Max. Marks - 60 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. Course objective: The course is designed to acquaint the students with decision-making in planning, scheduling and control of production and materials management. Course contents: Nature and scope of production management ; Locating production and service facilities ; Layout planning and analysis ; Types of manufacturing systems and layout – mass production, batch production and job shop production ; Maintenance management ; Capacity planning ; Product planning and selection ; Process planning ; Aggregate planning and Master production scheduling ; Product management – project planning, project scheduling, PERT and CPM use.– concept and classification of products ; product management decisions ; product mix decisions ; role of product manager ; organizing for new product development, strategic alliances for new product development, new product development process, financial analysis for product development. Environmental analysis ; identifying competitive set ; competitor analysis – sources of information and process ; category attractiveness analysis – product life cycle, product portfolio approach and matrix approach ; customer analysis ; estimating market potential and sales forecasting ; product positioning ; product strategies; financial analysis for product development ; test marketing and new product launch. Materials management – An introduction to materials management, Material requirement, Purchase management, Inventory control, Material handling ; Vendor selection, Make or buy decision, Negotiation ; Cost-reduction techniques –standardization, codification and variety reduction ; Waste management ; Value analysis ; Determination and description of material quality – acceptance sampling plan. Suggested Readings:

1. Admn, E.E.and Ebert, RJ : Production and Operations Management, 6th Edition, N. Delhi,

Prentice Hall of India, 1995. 2. Chunawalla and Patel : Production and Operations Management, Himalaya Publishing House. 3. Gopalakrishnan, P and Sundarshan, M : Handbook of Materials Management, N. Delhi,

Prentice Hall of India,1994. 4. Dutta, A.K.: Integrated Materials Management, N. Delhi, PHI, 1986. 5. Buffa, E. S. and Sareen : Modern Production Management, New York, John Wiley, 2002. 6. Chary : Theory and Problems in Production and Operations Management, Tata Mc Graw Hill,

N.Delhi. 7. Nair : Production and Operations Management, First Edition, Tata Mc Graw Hill, N.Delhi. 8. Gray and Larson : Project Management-The Managerial Process, Tata Mc Graw Hill, N.Delhi.

MPH-253: BUSINESS LAWS AND REGULATORY AFFAIRS

4 Hours/week Max. Marks - 60 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus.

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Course Objective: The course aim is to provide insights into the business regulatory framework and business laws relevant to pharmaceutical industry. Course Contents: The Indian Contract Act, 1872 – meaning and essentials of contract ; Offer and Acceptance ; Capacity of the parties ; Consideration ; Free consent ; Legality of object ; Performance ; Discharge and remedies for breach of contract. Sale of Goods Act, 1930 – relevant provisions. Companies Act, 1956 – meaning, characteristics and types of companies ; Formation of company ; Meaning and contents of Memorandum of Association and Articles of Association ; Company management and managerial remuneration ; Company meetings and proceedings Regulatory Environment – Investigational new drug application (INDA) and new drug application (NDA); New drug development process, product development and research; Pharmaceutical policy, 2002; Process validation, analytical and bio-analytical development and research. Intellectual property right (IPR) and Indian Pharmaceutical Sector: Various treaties governing IPR; Dunkel proposal; TRIPS & TRIMS and their implications for developing nations; Biodiversity and bio-technological patents; New developments in IPR and regulatory aspects – known substance, parallel exclusivity, exclusive marketing rights, Bolar provision, Para IV filling, strategic patenting. An overview of:

The Consumer Protection Act, 1986. The Foreign Exchange Management Act, 1999. The MRTP Act, 1969 and Competition Act, 2002.

Suggested Readings: 1. Kapoor, N.D. : Essentials of Company law, Sultan Chand and Sons. 2. Tulsan, PC : Business law, Tata Mc Graw Hill. 3. Majumdar, A.K., Kapoor G.K : Company Law, Taxmann, N.Delhi. 4. Datey, V.S.: Business and Corporate Laws, Taxmann, N.Delhi. 5. Kapoor, G. K.: Business laws, Taxmann, N.Delhi. 6. Aggarwal, Rohini : Mercantile and Commercial Laws, Taxmann, N.Delhi. 7. Kuchhal, MC : Business Law includes IT Law with commentary, Vikas publishing House,

N.Delhi. 8. Bargrial, K Askok : Company Law, Vikas Publishing House, N.Delhi. 9. Datey V.S : Business and Corporate Laws, Taxmann, N.Delhi.

MPH-: 254 STRATEGIC AND BRAND MANAGEMENT 4 Hours/week Max. Marks - 60 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. Course Objective: The course aim is to provide insights into the strategic decision-making and developing a strategic vision. Course Contents: Concept of Strategy – defining strategy, characteristics and approaches to strategic decision-making; Strategic management process; Developing a strategic vision, mission and setting objectives; Environmental appraisal – concept and components of environment; Analyzing the external (general and industry) environment; Organizational appraisal; Dynamics of internal environment, methods and techniques of organizational appraisal. Generic strategy alternatives – stability, expansion, retrenchment and combination strategies; variations strategy - Internal and external alternatives, related and unrelated alternatives, horizontal and vertical alternatives ; International level strategic alternatives; Strategic choice-choice process, choice techniques, managerial factors.Strategy implementation – the challenges of change and

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organizational learning, context levers, system levers, action levers ; Strategic evaluation and control – need, process and techniques. Brand – meaning, features and types ; brand personality ; launching the brand ; brand positioning and repositioning ; brand extensions ; brand equity – concept and methods ; brand transfers ; managing global brands. Suggested Readings:

1. Bhattacharya S.K and Venkataramia N : Managing business enterprises: strategies, structure and systems, Vikas Publishing House, N.Delhi.

2. Ferrel Lucas and Luck : Marketing strategy, Dryden Press. 3. Sontakki C.N : Strategic Management, Kalyani Publishers, N. Delhi. 4. Jauch and Glueck : Business policy and Strategic Management, Tata Mc Graw Hill, N. Delhi. 5. Kazmi, Azhar : Business policy, Tata Mc Graw Hill Publishing Co.Ltd., N. Delhi. 6. Miller, Alex : Strategic Management, Irwin Mc Graw Hill , Boston. 7. Rao, Subba P : Business policy and Strategic Management, Himalaya Publishing House, Delhi.. 8. Jean-Neol Kapferer : The New Strategic Brand Management, Kogan Page India Pvt. Ltd. 9.

Moorthi, Y.L.R. : Brand Management, The Indian Context, Vikas Publishing House Pvt. Ltd. 10. Majumdar, Ramanuj : Product Management in India, Prentice Hall of India, N. Delhi.

MPH-255 : SALES AND RETAIL MANAGEMENT

4 Hours/week Max. Marks - 60 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. Course Objective: To acquaint students with the basic concepts and techniques of Sales and Retail Management. Course Contents: Sales Management – concept, objectives and functions ; Integrating sales and marketing management ; Personal Selling – concept and classification of sales jobs, buyer-seller dyads ; personal selling process ; Prescription, behavior and research ; Sales planning – importance, approaches and process of sales planning ; Sales forecasting ; Sales budgeting ; Sales organization – purpose, principles and process of setting up a sales organization, sales organization structure, field sales organization, determining size of sales force ; Determining sales territories and time management, designing and administration of different types of sales quotas ; Managing Sales force – Recruitment ; Selection ; Training ; Compensation ; Motivating and leading the sales force ; Sales meetings and contents, Control process – Analysis of sales volume ; marketing costs and profitability analysis ; management of sales force expenses ;evaluating sales force performance. Retail management – concept, functions, importance and challenges in retail business ; theories of retailing ; classification of retail institutions on the basis – ownership, merchandise offered, store based and non- store based retailing ; strategic planning in retailing ; application of IT in retailing. Product – concept and classification of products ; product management decisions ; product mix decisions ; role of product manager ; organizing for new product development, strategic alliances for new product development, new product development process, financial analysis for product development. Environmental analysis ; identifying competitive set ; competitor analysis – sources of information and process ; category attractiveness analysis – product life cycle, product portfolio approach and matrix approach ; customer analysis ; estimating market potential and sales forecasting ; product positioning ; product strategies; financial analysis for product development ; test marketing and new product launch. Suggested Readings:

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1. Gupta S.L ; Sales and Distribution Management, Excel Books. 2. Anderson, Hair Bush ; Professionall Sales Management, Mc Graw Hill, Sngapore. 3. Dalrymple, D.J and W.J. Cron ; Sales Management –concepts and cases, John Wiley, New York. 4. Ford, Churchill, Walker ; Management of sales force, Mc Graw Hill, Singapore. 5. Johnson, Kurtz, Schewing ; Sales Management, Mc Graw Hill, Singapore. 6. Krik, C.A ; Salesmanship, taraporewala, Bombay. 7. Lancaster G ; Selling and Sales Management, Macmillan, N. Delhi. 8. Stanton W.J. and R. Shapiro ; Management of Sales force, Mc Graw Hill, Singapore. 9. Still, Richard R., Edward W. Candiff and Norman A.P Govoni ; Sales Management, prentice

Hall, N. Delhi. 10. Gilbert David :Retail Marketing Management, Pearson Education, N.Delhi. 11. Pradhan, Swapna : Retail Management - Text and Cases, Tata McGraw Hill, N. Delhi. 12. Bermans and Evans : Retail Management – A Strategic Approach, Prentice Hall of India, N.

Delhi. MPH – : 256 HOSPITAL MANAGEMENT AND ADMINISTRATION 4 Hours/week Max. Marks - 60 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. Course objective: The course is designed to acquaint the students with the planning, administration, organizational structure and control of hospitals. Course contents : Hospital – meaning, characteristics, role and functions of medical services ; systems view of hospitals ; health care systems – primary, secondary and tertiary ; classification of hospitals ; hospital planning and designing location and layout. Outpatient and inpatient services ; nursing services ; clinical support services – radiology/diagnostic services ; operating department ; medical records ; pharmacy and central sterile supply department. Planning process for hospitals; hospital administration – role and responsibilities of hospital administrator; hospital organization – structure and functions; types of hospital committees; directing the hospital staff – training, leading, motivating and communication ; controlling and evaluating hospital performance. Managing service quality - need, mandatory requirements, constraints ; quality management programs – development process, tools and techniques ; control of hospital acquired infection and role of CSSD ; hospital waste management. Suggested Readings :

1. Gupta Shakti, Dave,P.K : Hospital Stores management-An Integrated Approach, Jaypee Brothers Medical Publishers, N. Delhi.

2. Francis CM, de Souza Mario : Hospital Management,Third Edition, Jaypee Brothers Medical Publishers, N. Delhi.

3. Pankaj Mohan, Montague A. Gary, Glassey Jarka : Pharmaceutical Operations Management, McGraw Hill, N.Delhi.

4. Sakharkar BM : Principles of Hospital Administration and Planning, Jaypee Brothers Medical Publishers, N. Delhi.

5. Goodwin : Managing Health Services, First Edition, Tata Mc Graw Hill, N.Delhi.

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INSTITUTE OF PHARMACEUTICAL SCIENCES, KURUKSHETRA UNIVERSITY KURUKSHETRA

Syllabus: M. Pharm. (Pharmaceutics) First Semester

Paper – I

MPH - 101: MODERN PHARMACEUTICAL AND ANALYTICAL TECHNIQUES 4 hours/week Max. Marks 80 Note: The paper setter will set 7 questions (First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus; three question from section A and one question from each section B, C and D); out of which the candidate will be required to attempt 5 questions in all and atleast one question from each section. All questions will carry equal marks. A. Pharmaceutical Chemistry (27 h)

1. Infrared Spectroscopy (04 h) Introduction, the infrared absorption process, the modes of vibrations, stretching and bending, bond properties and absorption trends, basics of instrumentation techniques, pharmaceutical applications.

2. Ultraviolet Spectroscopy (03 h) Introduction, the nature of electronic excitation, the origin of uv band structure, principle of absorption spectroscopy, chromophore- σ→σ*, η→σ*, π→π* transitions, basics of instrumentation techniques, pharmaceutical applications.

3. Nuclear Magnetic Resonance Spectroscopy (04 h) Introduction, nuclear spin states, nuclear magnetic moments, absorption of energy, the mechanism of resonance, chemical equivalence, spin-spin coupling, basics of instrumentation techniques, pharmaceutical applications.

4. Mass Spectrometry (05 h) Basic principle and theory involved, basics of instrumentation techniques, pharmaceutical applications.

5. Thermal Analysis (07 h) Introduction to various thermal methods of analysis, basic principles and theory, instrumentation and pharmaceutical applications of thermo gravimetric analysis (TGA), differential thermal analysis (DTA), differential scanning calorimetry (DSC) and microcalorimetry, different types of calorimeters and micro calorimeters, advantages of microcalorimetry over DSC.

6. Optical Rotatory Dispersion and Circular Dichroism (04 h) Definition, theory and instrumentaton of ORD and CD. Cotton effect, Octant rule and its applications B. Pharmaceutics (13 h)

1. Basic elements of Novel drug delivery systems. 2. Bioavailability and bioequivalence testing, significance of terminology, conduct of

bioavailability trials. 3. Introduction to validation of manufacturing facilities I.Q. / O.Q. and certification, preparation of

validation protocols. 4. Stability testing: Stress testing of drug substances, stability testing protocols, shelflife

determination, ICH guidelines. C. Pharmacognosy (10 h)

Plant tissue culture: Conventional breeding v/s tissue culture, Applications of Plant tissue culture technique,Tissue culture media (composition & preparation), Preparation of explant, Sterilization

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techniques, Type of cultures, Protoplast technology and its applications, Immobilization techniques and their applications, Tissue culture as a technique to produce novel plants and hybrids, Factors affecting the production of secondary metabolites from tissue- culture.

D. Pharmacology (10 h) Definition of bioassay, various types of bioassays, advantages and limitations of bioassays with suitable examples, Theory and application of radioimmunoassay and ELISA. Animal models for screening of anti-inflammatory, anti-convulsant, and anti-diabetic.

Reading Material Recommended 1. Silverstein RM and Webster FX. Spectrometric Identification of Organic Compounds. John Wiley and

Sons, New York. Latest Edition. 2. Pavia DL, Lampman GM and Kriz GS. Introduction to Spectroscopy. Harcourt College Publishers,

Orlando. Latest Edition. 3. Vogel HG and Vogel WH. Drug Discovery and Evaluation. Springer-Verlag, Berlin. Latest Edition. 4. Kulkarni SK. Handbook of Experimental Pharmacology. Vallabh Prakashan, New Delhi. Latest Edition. 5. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata. Latest Edition. MPH 102: MODERN PHARMACEUTICAL AND ANALYTICAL TECHNIQUES PRACTICAL 4 Hours/week Max. Marks: 80 Modern experiments having relevance to the topics covered under theory. Reading Material Recommended 1. Indian Pharmacopoeia, Central Indian Pharmacopoeia Laboratory, Govt. of India, Ministry of Health &

Family Welfare, Ghaziabad, Latest Edition. 2. U. S. Pharmacopoeia – NF, The United States Pharmacopoeial Convention, Rockville, USA, Latest

Edition. 3. European Pharmacopoeia, Directorate for the Quality of Medicines of the Council of Europe

(EDQM), Strasbourg, Europe, Latest Edition. 4. British Pharmacopoeia, The Stationary Office on behalf of the Medicine Health Care Product

Regulatory Agency (MHRA), London, Latest Edition. 5. Mendham J, Denney RC, Barnes JD and Thomas M. Vogel’s Textbook of Quantitative Chemical

Analysis. Pearson Education Limited, Singapore. Latest Edition. 6. Silverstein RM and Webster FX. Spectrometric Identification of Organic Compounds. John Wiley and

Sons, New York. Latest Edition. 7. Vogel HG and Vogel WH. Drug Discovery and Evaluation. Springer-Verlag, Berlin. Latest Edition. 8. Kulkarni SK. Handbook of Experimental Pharmacology. Vallabh Prakashan, New Delhi. Latest Edition. 9. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata. Latest Edition.

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MPH - 111: PHARMACEUTICS-I (PRODUCT DEVELOPMENT & QUALITY ASSURANCE) 4 Hours/week Max. Marks 80

Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus.

1. Preformulation: Objectives, methodology, physicochemical parameters viz. pKa and solubility, partition coefficient, log P values estimation, polymorphism, surface characteristics, compatibility tests, applications of solubility parameters in the development of solid, oral liquid and parenteral dosage forms. (05 h)

2. Pilot plant scale up techniques: Significance, scale-up techniques for tablets, capsules and liquid orals involving specific considerations e.g. formula, equipment product uniformity, stability, processing, physical layouts, personnel required, legal and regulatory aspects. (08 h)

3. Production management and documentation: GMP considerations, quality control, quality assurance, process control, total quality management and productivity, process and equipment Validation for solid formulations and parenterals, basic principles of materials management and cost control, ISO- 9000 series, intellectual property rights, national and international patent procedures. (10 h)

4. Optimization procedures in formulation & processing: Optimization parameters advanced modern techniques, statistical design & applied optimization methods. (08 h)

5. Drug stability: Shelf-life determination, overages, accelerated stability testing, packaging influence on stability, factors affecting stability of pharmaceutical products (09 h)

6. Dosage forms: Theoretical and practical aspects in the manufacture and evaluation of following dosage forms: a) Solid dosage forms-tablets, capsules, microcapsules b) Liquid dosage forms-suspensions, emulsions (20 h)

RECOMMENDED READINGS: 1. Theory and Practice of Industrial Pharmacy - Lachman, L. and Liberman, H.A. 3rd ed., Varghese

Publishing House, Bombay. 2. Pharmaceutical Dosage Forms - Tablets, Vols. - I, II and III - Lachman, L. and Liberman, H.A. 2nd ed.,

Revised and Expanded, Marcel Dekker, Inc. 3. Modern Pharmaceutics - Banker, G.S. and Rhodes 4th ed.,Marcel Dekker, Inc. 4. Physical Pharmacy - Martin, A., 4th ed.; Lippincott Williams and Wilkins. 5. Bentley's Textbook of Pharmaceutics -:- Rawlins, E.A., All India Traveller Book seller, New Delhi. 6. Pharmaceutical Dosage Forms and Drug Delivery Systems – Ansel, 8th ed., Lippincott Williams and

Wilkins. 7. The Science and Practice of Pharmacy. Remington, 20th ed., Lippincott Williams and Wilkins. 8. Encyclopedia of Pharmaceutical Technology- Swarbrick and Boylan 2nd ed. Marcel Dekker, Inc. 9. Pharmaceutical Dosage Forms-Parenteral Medications-Vol. - I, II and III Avis K.E., Lachman L. and

Lieberman H.A, 2nd ed. , Revised and Expanded, Marcel Dekker, Inc.

MPH - 112: PHARMACEUTICS-II (ADVANCED PHARMACEUTICS-I) 4 Hours/week Max. Marks: 80 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. A detailed study of the cosmetic preparations/regulatory standards/safety testing of cosmetics, including recent advancements:

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1. Raw materials used for cosmetic preparation: Detailed knowledge of various raw materials used in cosmetic industry like surfactants, humectants, cream bases, perfumes, colours etc. (06 h)

2. Cosmeceuticals: Cosmeceutical actives, application of cosmeceuticals. (04 h) 3. Hair care products: Introduction, hair structure, shampoos, conditioners, styling aids, setting lotion, hair

creams, bleaches and hair dyes. (08 h) 4. Skin care products: Introduction, anatomy and physiology of skin, formulation of skin cleaners,

moisturizers, sunscreen products and acne products. (08 h) 5. Colour cosmetics: Introduction, lip colour, nail polish, face make up and eye make-up. (06 h) 6. Dental products: Dentrifices, oral rinses, tooth powder and tooth paste. (05 h) 7. Herbal cosmetics: Formulation development and evaluation. (06 h) 8. Regulatory requirements: Legal/ Regulatory standards/systems governing cosmetic products- Indian:

BIS standards and International - U.S.A (07 h) 9. Safety testing of cosmetic products: Various microbial contaminants in cosmetic products, selection

criteria for preservatives, Efficacy and safety testing of preservatives in cosmetic products, stability evaluation of cosmetic products. (10 h)

RECOMMENDED READINGS 1. Handbook of cosmetic science and technology-Knowlton, J. and Rearce, S. 2. Harry’s Cosmetology- Wilkinson, J.B. and Moore, R.J. 3. Modern cosmetics-Thomssen, E.G. 4. Cosmetic Technology- Nanda, A. and Khar, R.K. 5. Cosmetic Ingedients, their safety assessment- Elder,R.L. 6. Cosmetic Product Testing- Moskowitz , H.R. MPH-113: PHARMACEUTICS-III (ADVANCES IN DRUG DELIVERY SYSTEMS-I)

4 Hours/week Max. Marks: 80

Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus.

1. Fundamentals of Novel Drug Delivery: Rationale of sustained/controlled release (CR), physicochemical and biological factors influencing design and performance of CR products. Theory of mass transfer: Fick’s laws and their applications in drug release, Pharmacokinetic and Pharmacodynamic basis of NDDS. (08 h)

2. Polymers in CR: Classification, properties biocompatible and biodegradable polymers. Modeling of drug release from porous polymer; drug release from non-porous and hydrophobic polymers. Diffusional release and dissolution controlled release from monolithic devices, microporous systems. (08 h)

3. Oral Controlled Drug Delivery Systems: Oral systems based on dissolution, diffusion and other mechanism. pH control on exchange resins, gel diffusion, osmotic pumps. Hydrodynamically balanced system, Modulation of GIT transit. (08 h)

4. Mucosal Drug Delivery System: Mechanism of trasmucosal permeation, mucous membrane model, buccal, nasal, pulmonary drug delivery system. (07 h)

5. Ocular Drug Delivery Systems: Classification, fabrication and application of ocuserts. (05 h)

6. Parenteral Drug Delivery Systems: Biopharmaceutical considerations. Solutions, suspensions and emulsions. Implantable therapeutic systems. (06 h)

7. Transdermal Drug Delivery Systems: Drug absorption through skin, basic components of TDDS, types and techniques for development and evaluation. Iontophoresis and Sonophoresis, Drug permeation enhancers. (10 h)

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8. Biochemical and Molecular Biology Approaches to CDDS: a) Microparticulate drug carriers- structural aspects, preparation, characterization and applications of

microspheres. b) Monoclonal antibodies- preparation and applications. (08 h)

RECOMMENDED READINGS 1. Novel Drug Delivery Systems – Chien, Y.W. 2. Controlled Drug Delivery Systems – Robinson, J.R. and Vincent, H.L. 3. Treatise on Controlled Drug Delivery – Kydoneus, A. (Ed.) 4. Targetted Therapeutic Systems – Tyle, P and Ram, B.P. 5. Controlled Drug Delivery, Vols. I & II – Bruck, S.D. 6. Microencapsulation – Deasy, P.B. 7. Transdermal Drug Delivery – Kydoneus, A. 8. Opthalmic Drug Delivery Systems – Mitra, A.K.

MPH 114: PHARMACEUTICS PRACTICAL-I 12 Hours/Week Max. Marks: 120 Number of practicals based on aforementioned theory papers, MPH-111, 112 and 113.

Second Semester

MPH – 201: BIOSTATISTICS AND INTELLECTUAL PROPERTY RIGHTS 4 Hours/week Max. Marks - 80

Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus.

Intellectual Property Rights

1. Intellectual Property Concepts and fundamentals: The emergence and growth of the concepts regarding intellectual property (IP), intellectual property protection (IPP) and intellectual property rights (IPR); economic importance, mechanism for protection of intellectual property - patents, copyright, trademarks; role of IP in pharmaceutical industry; global ramifications and financial implications. (10 h) 2. Trade Related Aspects of Intellectual Property Rights Intellectual property and international trade, concept behind WTO (World Trade Organization), WIPO (World Intellectual Property Organization), GATT (General Agreement on Tariff and Trade), TRIPs (Trade Related Intellectual Property Rights),TRIMS (Trade Related Investment Measures) and GATS (General Agreement on Trades in Services), status in India and other developing countries, case studies and examples, TRIPS issues on herbal drugs. (10 h) 3. Nuts and Bolts of Patenting Copyright and trade mark protection, criteria for patentability, Indian patent act. 1970: WTO and modifications under TRIPS, filing of a patent application, precautions before patenting-disclosures/non-disclosures, publication-article/ thesis, prior art search – published patents search, internet search patent sites, specialized service search requests, costs, patent application forms and guidelines, fee structure, time frames, jurisdiction aspects, types of patent application - provisional, nonprovisional, PCT and convention patent applications, international patenting requirement procedures and costs. Patent infringement: Meaning, scope, litigation, drug related patents infringements, case studies and examples, patenting by research students. Trademarks legislation and registration system in India - an introduction, meaning of trademark, criteria for eligibility, filling application for trademark registration, trade secrets - scope modalities and protection case studies. (15 h)

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4. Ethics and Values in IP IP and ethics, positive and negative aspects of IPR, social responsibility, avoiding unethical practices, eco-responsibility–economic, social and environmental benefits of modern biotechnology. (05 h) Biostatistics General concepts, two-tail student t-test and paired sample t-test, two samples t-test, Wilcoxon rank-sum test, Mann-Whitney test, one-way analysis of variance, Kruskal-Wallis test, two-way analysis of variance, multiple comparison procedures in ANOVA: Fischer’s LSD test, Tukey’s studentized range test and Dunnett’s test. Non-linear regression: Introduction, iterative method. Correlation, linear regression, PCA and PLS. (20 h) READING MATERIAL RECOMMENDED 1. Treece DJ. Managing Intellectual Capital: Organizational, Strategic and Policy Dimension. Oxford

University Press, England. Latest Edition. 2. Wadedhra BL. Law Relating to Patents, Trademarks, Copyright Design and Geographical Indications.

Universal Law Publishing, New Delhi. Latest Edition. 3. Bansal P. IPR Handbook for Pharma Students and Researchers, Pharma Book Syndicate, Hyderabad.

Latest Edition. 4. Copyright Protection in India [website: http:copyright.gov.in]. 5. Information on Orange Book [website: www.fda.gov/cder/ob/default.htm]. 6. World Trade Organization [website: www.wto.org]. 7. Trivedi PR. Encylcopedia of Intellectual Property Rights. Jnanada Prakashan, New Delhi. Latest Edition. 8. Arya P. P. and Yashpal, Research Methodology in Management, Deep and Deep publications Private

Limited, New Delhi. 9. Green and Tull : A research for marketing research decisions, PHI (P) Ltd. New Delhi. 10. Karishna Swami, Shiva Kumar & Mathirajan, Management Research Methodology, Pearson Education. 11. Hooda, R P, Statistics for Business and Economics, MacMillan India Limited, New Delhi. 12. Heinz, Kohler: Statistics for business and Economics, Harper Collins. 13. Lawrence B Morse: Statistics for business and economics, Harper Collins. 14. Levin, Richard I. & David S Rubin: Statistics for management PHI Delhi. MPH - 211: PHARMACEUTICS-IV (BIOPHARMACEUTICS & ADVANCED PHARMACOKINETICS) 4 Hours/week Max. Marks: 80 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. 1. General Principles: Drug Absorption, Distribution, Metabolism & Excretion. Factors affecting these

processes. Concepts of Bioavailability & bioequivalence, protein binding. (12 h) 2. Review of Compartment Approaches: Terminology, Kinetics of single and multiple dose

administration, one and two compartment models, basics of Pharmacokinetics and Chronopharmacokinetics. (08 h)

3. Non-compartmental Pharmacokinetics: Model independent approaches and their advantages, stochastic approach and statistical moment theory, determination of AUC, AUMC, MRT, MDT, MTT and MAT. Advanced techniques like log-trapezoidal, spline and Lagranges, Computation of statistical moments from plasma and urine data, pharmacokinetic evaluation of Cl, Vd and t1/2. Linear Recirculation Models. (08 h)

4. Clinical Pharmacokinetics: Kinetics of pharmacological response, explanation of clinical response via pharmacokinetics. Monitoring of Plasma concentration of drug during clinical use, clinical relevance of

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kinetic studies, turnover concepts. Individualization of dosage regimen, reasons of variability – genetics, age, weight, disease, drug interaction, etc. (08 h)

5. In Vitro-In Vivo Correlations: Drug dissolution, principles and methodology, different methods of in vitro-in vivo correlation, their applications and limitations. (08 h)

6. Controlled release dosage forms: Bioavailability and pharmacokinetics of oral, parenteral, ocular, transdermal CRDF and IUDs. (07 h)

7. Computer Applications and Pharmacokinetics: Introduction and study of computer software for pharmacokinetics. (05 h)

8. Pharmacokinetic and Pharmacodynamic (PK/PD) models. (04 h) RECOMMENDED READINGS 1. Biopharmaceutics & Clinical Pharmacokinetics – Gibaldi, M. 2. Biopharmaceutics & Pharmcokinetics – Notari, R.E. 3. Biopharmaceutics – Swarbrick 4. Applied Biopharmaceutics & Pharmacokinetics – Shargel, L. 5. Dissolution Bioavailability & Bioequivalence – Abdov, H.M. 6. Clinical Pharmacokinetics: Concepts and Applications – Rowland, M. and Tozer, T.N. 7. Fundamentals of Clinical Pharmacokinetics- Wagner, J.G. MPH -212: PHARMACEUTICS-V (ADVANCED PHARMACEUTICS-II) 4 Hours/week Max. Marks: 80

Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus.

SECTION-A A detailed study of the following sterile product technological/packaging aspects, including recent advancements: 1. History of parenteral medication, development and packaging of parenterals, types of preparations.

Vehicles and added substances for parenterals, sterile suspensions and ophthalmic solutions. (08 h)

2. Environmental control, personnel, packaging components, product preparation, control and labeling. (04 h)

3. Parenteral admixtures and incompatibilities. Fundamentals of fluid and electrolyte therapy. Radiopharmaceuticals used in parenterals. Parenteral devices such as syringes, cannula, catheters, hazards associated with parenteral therapy. (06 h)

SECTION-B

A detailed study of the following pharmaceutical packaging materials/containers/machines, including recent advancements:

1. Glass and plastic containers for pharmaceuticals: types, their manufacture, basic steps in container design and development, chemical performance, testing and biological toxicity. Flexible packaging and type of films. (08 h)

2. Paper and paper board: Types of paper, folding cartons, quality control testing of paper and paper board; Corrugated boxes. (05 h)

3. Metal container: Aluminium and tin-plated drums, collapsible tubes and aerosol containers. (lacquering, coating and lining). (05 h)

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4. Caps and closures: Various types of closures, child-resistant caps, emphasis on elastometric closure for parenterals, methods of evaluation of closures. (06 h)

5. Labels and labeling: Types of labels, adhesives, bar-coding, legal requirements of labeling, new developments in labeling technologies. (04 h)

6. Pharmaceutical packaging machinery including strip packaging, blister packaging, and pouch packaging machinery. (06 h)

7. Pharmaceutical product-package compatibility, effect of packaging components on stability, packaging selection, Tamper evident packaging. (04 h)

8. Environmental considerations of packaging materials along with national and international regulations. (04 h)

RECOMMENDED READINGS 1. The Theory & Practice of Industrial Pharmacy, 3rd edition, Leon Lachman, Herbert A. Lieberman,

Joseph. L. Karig, Varghese Publishing House, Bombay. 2. Pharmaceutical Dosage forms - Parenteral Medications, Vol 1 to 3, Kenneth E. Avis, Herbert A.

Leiberman, Leon Lachman, Marcel Dekker Inc., New York. 3. Introduction to Pharmaceutical Dosage Forms, Hourared C. Ansel, 4th edition, Varghese Publishing,

Bombay. 4. Quality control of Packaging Materials in the Pharmaceutical Industry, Kenneth Herburn, Marcel

Dekker, Inc., New York. 5. E.A.Rawlins, Bentley’s Textbook of Pharmaceutics, University Printing House, Oxford, 1998. 6. AI Brody & K S Marsh, “The Wiley Encyclopedia of Packaging Technology”, John Wiley & Sons,

New York. 7. T C KacChesney, “Packaging of Cosmetics and Toiletries”, Newness- Butterworth, London. 8. “Remington’ Pharmaceutical Sciences”, Mack Publishing Co., P.A. MPH- 213: PHARMACEUTICS-VI (ADVANCES IN DRUG DELIVERY SYSTEMS-II)

4 Hours/week Max. Marks: 80

Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. 1. Colloidal and Supramolecular Delivery Systems (24 h) (a) Closed bilayered system: Historical background, structural aspects, preparation, characterization,

evaluation and applications, specialized liposomes in drug targeting; Niosomes, erythrosomes, pharmacosomes, aquasomes and solid lipid nanoparticles (SLNs).

(b) Multiple w/o/w emulsions as drug vehicles: Introduction, composition of the multiple emulsion and stability, influence of the nature of oil phase, methods for stabilizing w/o/w multiple emulsions, mechanisms of transport of solutes, in-vivo studies.

(c) Microemulsions: Introduction, structure of microemulsions, solubilization and formulation of microemulsions, transport properties and pharmaceutical applications of emulsions.

2. Protein and Peptide Drug Delivery (12 h) Considerations in the physiological delivery of therapeutic proteins: Carrier mediated transport of peptides and peptide analogues, problems associated with the delivery of protein and peptides, stability and membrane barriers, delivery systems for protein and peptide drugs, toxicity aspects, enzyme and enzyme immobilization, recent trends in vaccine and vaccine delivery systems.

3. Triggered, Pulsed and Programmed Drug Delivery Systems (06 h) 4. Targeted Drug Delivery (12 h)

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Basic principles of drug targeting, Introduction to approaches for drug delivery with special reference to organ targeting (e.g. brain, tumor and lung).

5. Herbal Product Development (06 h) Background and present scenario, formulation considerations, major hurdles and challenges, future prospects.

RECOMMENDED READINGS 1. Robinson JR and Lee VHL. Controlled Drug Delivery - Fundamentals and Applications. Vol. 29 and Vol.

31, Marcel Dekker, New York. Latest Edition. 2. Bruck SD. Controlled Drug Delivery. Vol. I (Basic Concepts), CRC Press, Florida. Latest Edition. 3. Bruck SD. Controlled Drug Delivery. Vol. II (Clinical Applications), CRC Press, Florida. Latest Edition. 4. Tyle P and Ram B. Targeted Therapeutic Systems, Marcel Dekker, New York. Latest Edition. 5. Vyas SP and Khar RK. Targeted and Controlled Drug Delivery. CBS, New Delhi. Latest Edition. 6. Jain NK. Advances in Controlled and Novel Drug Delivery. CBS, New Delhi. Latest Edition. MPH 214: PHARMACEUTICS PRACTICAL-II 12 Hours/Week Max. Marks: 120 Number of practicals based on aforementioned theory papers, MPH - 211, 212 and 213.

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INSTITUTE OF PHARMACEUTICAL SCIENCES, KURUKSHETRA UNIVERSITY KURUKSHETRA

Syllabus: M. Pharm. (PHARMACOLOGY) First Semester

Paper – I

MPH - 101: MODERN PHARMACEUTICAL AND ANALYTICAL TECHNIQUES 4 hours/week Max. Marks 80 Note: The paper setter will set 7 questions (First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus, three question from section A and one question from each section B, C and D); out of which the candidate will be required to attempt 5 questions in all and atleast one question from each section. All questions will carry equal marks. A. Pharmaceutical Chemistry 27h

1. Infrared Spectroscopy Introduction, the infrared absorption process, the modes of vibrations, stretching and bending, bond properties and absorption trends, basics of instrumentation techniques, pharmaceutical applications. 4h

2. Ultraviolet Spectroscopy Introduction, the nature of electronic excitation, the origin of uv band structure, principle of absorption spectroscopy, chromophore- σ→σ*, η→σ*, π→π* transitions, basics of instrumentation techniques, pharmaceutical applications. 3h

3. Nuclear Magnetic Resonance Spectroscopy Introduction, nuclear spin states, nuclear magnetic moments, absorption of energy, the mechanism of resonance, chemical equivalence, spin-spin coupling, basics of instrumentation techniques, pharmaceutical applications. 4h

4. Mass Spectrometry Basic principle and theory involved, basics of instrumentation techniques, pharmaceutical applications. 5h

5. Thermal Analysis Introduction to various thermal methods of analysis, basic principles and theory, instrumentation and pharmaceutical applications of thermo gravimetric analysis (TGA), differential thermal analysis (DTA), differential scanning calorimetry (DSC) and microcalorimetry, different types of calorimeters and micro calorimeters, advantages of microcalorimetry over DSC. 7h

6. Optical Rotatory Dispersion and Circular Dichroism Definition, theory and instrumentaton of ORD and CD. Cotton effect, Octant rule and its applications

4h B. Pharmaceutics

1. Basic elements of Novel drug delivery systems. 2. Bioavailability and bioequivalence testing, significance of terminology, conduct of bioavailability

trials. 3. Introduction to validation of manufacturing facilities I.Q. / O.Q. and certification, preparation of

validation protocols. 4. Stability testing: Stress testing of drug substances, stability testing protocols, shelflife

determination, ICH guidelines. 13h C. Pharmacognosy Plant tissue

culture: Conventional breeding v/s tissue culture, Applications of Plant tissue culture technique,Tissue culture media (composition & preparation), Preparation of explant, Sterilization techniques, Type of cultures, Protoplast technology and its applications, Immobilization techniques and their applications, Tissue culture as a technique to produce novel plants and hybrids, Factors affecting the production of secondary metabolites from tissue- culture. 10h

D. Pharmacology Definition of bioassay, various types of bioassays, advantages and limitations of bioassays with suitable examples, Theory and application of radioimmunoassay and ELISA. Animal models for screening of

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anti-inflammatory, anti-convulsant, and anti-diabetic. 10h

Reading Material Recommended 1. Silverstein RM and Webster FX. Spectrometric Identification of Organic Compounds. John Wiley and

Sons, New York. Latest Edition. 2. Pavia DL, Lampman GM and Kriz GS. Introduction to Spectroscopy. Harcourt College Publishers,

Orlando. Latest Edition. 3. Vogel HG and Vogel WH. Drug Discovery and Evaluation. Springer-Verlag, Berlin. Latest Edition. 4. Kulkarni SK. Handbook of Experimental Pharmacology. Vallabh Prakashan, New Delhi. Latest Edition. 5. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata. Latest Edition. MPH 102: MODERN PHARMACEUTICAL AND ANALYTICAL TECHNIQUES PRACTICAL 4 Hours/week Max. Marks: 80

Modern experiments having relevance to the topics covered under theory.

Reading Material Recommended 1. Indian Pharmacopoeia, Central Indian Pharmacopoeia Laboratory, Govt. of India, Ministry of Health &

Family Welfare, Ghaziabad, Latest Edition. 2. U. S. Pharmacopoeia – NF, The United States Pharmacopoeial Convention, Rockville, USA, Latest

Edition. 3. European Pharmacopoeia, Directorate for the Quality of Medicines of the Council of Europe

(EDQM), Strasbourg, Europe, Latest Edition. 4. British Pharmacopoeia, The Stationary Office on behalf of the Medicine Health Care Product

Regulatory Agency (MHRA), London, Latest Edition. 5. Mendham J, Denney RC, Barnes JD and Thomas M. Vogel’s Textbook of Quantitative Chemical

Analysis. Pearson Education Limited, Singapore. Latest Edition. 6. Silverstein RM and Webster FX. Spectrometric Identification of Organic Compounds. John Wiley and

Sons, New York. Latest Edition. 7. Vogel HG and Vogel WH. Drug Discovery and Evaluation. Springer-Verlag, Berlin. Latest Edition. 8.

Kulkarni SK. Handbook of Experimental Pharmacology. Vallabh Prakashan, New Delhi. Latest Edition. 9. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata. Latest Edition.

MPH - 131: PHARMACOLOGY-I

(PHARMACOLOGY AND PHARMACOTHERAPEUTICS) 4 Hours/Week Max. Marks - 80 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus.

1. Basic Principles of Clinical Pharmacology: 8 h Clinical pharmacokinetics, monitoring of drug therapy and adverse drug reactions, racial and ethnic differences in response to drugs, principles of pediatric and geriatric clinical pharmacology, drug therapy in pregnant and lactating mothers.

2. Drugs affecting autonomic nervous system: 6 h Parasympathomimetics, Parasympatholytics, sympathomimetics, sympatholytics, ganglion and neuromuscular blockers.

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3. Drug Therapy of Cardiovascular Disorders: 8h Pathophysiology and drug therapy of hypertension, congestive heart failure, angina, cardiac arrhythmias and hyperlipidemia.

4. Drug therapy of CNS disorders: 6h Pathophysiology and drug therapy of epilepsy, anxiety, depression, schizophrenia and Parkinson’s disease.

5. Drug Therapy of GIT disorders: 3h Pathophysiology and drug therapy of peptic ulcers, emesis, diarrhoea and constipation.

6. Drug Therapy of endocrine disorders: 3h

Drug therapy of diabetes mellitus, oral contraceptives, drugs affecting uterine motility.

7. Drug Therapy of respiratory disorders: Pathophysiology and drug therapy of asthma. 2h

8. Antineoplastic agents: Pharmacology of anticancer agents. 4 h 9. Drug Therapy of Inflammatory disorders: 3 h

Pathophysiology and drug therapy of rheumatoid arthritis and gout.

10. Chemotherapy: 17h General principles of chemotherapy, penicillins, cephalosporins, aminoglycosides, tetracyclines, macrolides, sulfonamides and fluorquinolones. Drug therapy of tuberculosis, leprosy, urinary tract infections, sexually transmitted diseases, viral diseases, fungal diseases, malaria, amoebiasis and helminthiasis.

RECOMMENDED READINGS: 1. Goodman and Gilman’s The Pharmacological Basis of Therapeutics, - McGraw- Hill Companies,

Inc. 2. B.G. Katzung, Basic and Clinical Pharmacology, Prentice Hall, International. 3. D.R. Lawrence and P.N. Bennett, Clinical Pharmacology, Churchill Livingstone, U.K. 4. H.P. Rang and M.M. Dale, Pharmacology, ELBS/Churchill Livingstone. 5. J. T. Dipiro, R.L. Talbert, P.E. Hayers, G.C. Yee and L.M. Possy (eds), Pharmacotherapy: A

Pathophysiological Approach, Appleton Lange, USA.

MPH - 132: PHARMACOLOGY-II (DRUG EVALUATION TECHNIQUES) 4 Hours/Week Max. Marks - 80 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. 1. Principles of Experimental Pharmacology: 10h Common laboratory animals in pharmacological research, limitations of animal tests, alternatives to animal use, anesthetics used in laboratory animals, euthanasia of experimental animals. CPCSEA guidelines for regulations for the care and use of laboratory animals. 2. Drug Discovery: 10h

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Strategies and approaches employed in drug discovery. OECD guidelines for toxicological evaluation of new drug entities. High throughput screening, cell lines, and their application in drug discovery. Transgenic animal models in the development of new drugs. 3. Pharmacological Techniques to evaluate the following Class of Drugs: 40h

1. Antihypertensive agents 2. Antiepileptics 3. Antiparkinsonian agents 4. Antianxiety agents and drugs used in mood and sleep disorders 5. Antipsychotics 6. Drugs affecting memory 7. Drugs used in Alzheimer’s disease 8. Local anesthetics 9. Skeletal muscle relaxants and neuromuscular blockers 10. Antidiabetic agents 11. Antifertility agents 12. Analgesics and drugs used in arthritis and neuropathic pain 13. Anti-inflammatory agents 14. Antiasthmatic agents 15. Antiulcer agents 16. Antiemetics 17. Drugs used in inflammatory bowel disease 18. Hepatoprotective agents 19. Antiobesity agents 20. Drugs used in erectile dysfunction 21. Antiviral agents 22. Antimalarial agents 23. Dermatological agents and experiment models in skin pharmacology

BOOKS RECOMMENDED 1. H.G. Vogel (ed), Drug Discovery and Evaluation-Pharmacological Assays, 2nd edition, Springer Verlag, Berlin, Germany, 2002. 2. M.N. Ghosh, Fundamentals of Experimental Pharmacology, 2nd edition, Scientific Book Agency, Calcutta, India, 1984. 3. D.R. Laurence and A.L. Bacharach (eds), Evaluation of Drug Activities: Pharmacometerics, Vol. 1 and 2, Academic Press, London, U.K., 1964. 4. David R. Gross, Animal Models in Cardiovascular Research, 2nd edition, Kluwer Academic Publishers, London, U.K., 1994. MPH - 133: PHARMACOLOGY– III

(DRUG DISCOVERY AND TOXICOLOGY) 4 Hours/Week Max. Marks - 80 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. 1. Introduction to Drug Discovery 6h History of drug discovery, sources of drugs (plants, animals, microorganisms, drugs from organic synthesis), existing drugs as a source of new drug, lead identification and optimization.

2. Preclinical Studies and Drug Development 12h Stages of drug discovery, pre-clinical and safety evaluation, acute, sub-acute, chronic studies, in-vivo and in-vitro studies (behavioral, biochemical, neurochemical models) and special studies including carcinogenicity, mutagenicity, teratogenicity.

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3. Novel Drug Targets for Drug Discovery 12h Exploration and investigation of therapeutic drug targets as enzymes, receptors, genes, platelets and matrix metalloproteases for drug design. 4. Toxicology 14h Concept, development and scope of toxicology, behavioural and neurotoxicity, teratology, endotoxin, pesticides, cardiac, hepatic, renal and pulmonary toxicity. Industrial, environmental and forensic toxicology, clinical toxicology, principles and management of different types of poisoning. 5. Immunotherapy 16h Introduction to immune system, cellular and humoral immunity, complement, antigen- antibody interactions, immunity to bacteria, virus, protozoa, and fungi, immunomodulators and immunosuppressants and their use in autoimmune disorders, principles and development of vaccines against different diseases. Reading Material Recommended

1. Bartfai T and Lee GV. Drug Discovery. Elsevier, New York. Latest Edition. 2. Huang Z. Drug Discovery Research. Wiley InterScience, USA. Latest Edition. 3. Evans RP, Drug and Biological Development. Springer, USA. Latest Edition. 4. Ricky NG. Drugs from Discover to Development. Wiley-Blackwell, USA. Latest

Edition. 5. Ballantyne B, Marrs T and Turner P. General and Applied Toxicology. Macmillan

Press Ltd., London. Latest Edition. 6. Goldsby RA, Kindt TJ and Osborne BA. Kuby’s Immunology. WH Freeman Book, New York.

Latest Edition. 7. Klaasen KCD and Amdur MA. Casarett & Doul's Toxicology. Mcmillan Press Ltd., London. Latest

Edition. MPH 134: PHARMACOLOGY PRACTICAL-I 12 Hours/week Max. Marks: 120

1. Practical Based on Pharmacology and Pharmacotherapeutics a) Bioassay of histamine using guinea pig / rat ileum. b) Bioassay of serotonin using rat fundus. c) Bioassay of oxytocin using rat uterus. d) Bioassay of acetylcholine using rat ileum preparation. e) Determination of pA2 value of atropine using acetylcholine as agonist employing rat ileum

preparation. f) To record CRC of noradrenaline using isolated rat anococcygeus muscle preparation. g) To study the effect of noradrenaline and acetylcholine on the coronary blood flow and heart rate of

rat isolated heart using Langendorff’s heart preparation. 2. Practical based on following Drug Evaluation Techniques

a) Antihypertensive agents b) Antiepileptics c) Antianxiety agents and drugs used in mood and sleep disorders d) Antipsychotics e) Drugs affecting memory f) Local anesthetics g) Skeletal muscle relaxants and neuromuscular blockers h) Antidiabetic agents i) Analgesics and drugs used in arthritis and neuropathic pain j) Anti-inflammatory agents k) Antiasthmatic agents l) Antiulcer agents m) Hepatoprotective agents

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3. Practicals realted to Toxicology Behavioural and neurotoxicity, teratology, endotoxin, pesticides, cardiac, hepatic, renal and pulmonary toxicity, environmental, forensic toxicology, and clinical toxicology.

RECOMMENDED READINGS:

1. Practical Pharmacology and Clinical Pharmacy by Professor S.K. Kulkarni, Vallabh Prakashan, Delhi.

2. Practical Pharmacology by Professor R. K. Goyal, B. S. Shah Prakashan, Ahemdabad. 3. 1. H.G. Vogel (ed), Drug Discovery and Evaluation-Pharmacological Assays, 2nd edition,

Springer Verlag, Berlin, Germany, 2002. 4. 2. M.N. Ghosh, Fundamentals of Experimental Pharmacology, 2nd edition, Scientific Book

Agency, Calcutta, India, 1984. 5. 3. D.R. Laurence and A.L. Bacharach (eds), Evaluation of Drug Activities: Pharmacometerics, Vol.

1 and 2, Academic Press, London, U.K., 1964. Second Semester MPH – 201: BIOSTATISTICS AND INTELLECTUAL PROPERTY RIGHTS 4 Hours/week Max. Marks - 80 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. Intellectual Property Rights 1. Intellectual Property Concepts and fundamentals: The emergence and growth of the concepts regarding intellectual property (IP), intellectual property protection (IPP) and intellectual property rights (IPR); economic importance, mechanism for protection of intellectual property - patents, copyright, trademarks; role of IP in pharmaceutical industry; global ramifications and financial implications. 10h 2. Trade Related Aspects of Intellectual Property Rights Intellectual property and international trade, concept behind WTO (World Trade Organization), WIPO (World Intellectual Property Organization), GATT (General Agreement on Tariff and Trade), TRIPs (Trade Related Intellectual Property Rights),TRIMS (Trade Related Investment Measures) and GATS (General Agreement on Trades in Services), status in India and other developing countries, case studies and examples, TRIPS issues on herbal drugs. 10h 3. Nuts and Bolts of Patenting Copyright and trade mark protection, criteria for patentability, Indian patent act. 1970: WTO and modifications under TRIPS, filing of a patent application, precautions before patenting-disclosures/non-disclosures, publication-article/ thesis, prior art search – published patents search, internet search patent sites, specialized service search requests, costs, patent application forms and guidelines, fee structure, time frames, jurisdiction aspects, types of patent application - provisional, nonprovisional, PCT and convention patent applications, international patenting requirement procedures and costs. Patent infringement: Meaning, scope, litigation, drug related patents infringements, case studies and examples, patenting by research students. Trademarks legislation and registration system in India - an introduction, meaning of trademark, criteria for eligibility, filling application for trademark registration, trade secrets - scope modalities and protection case studies. 15h 4. Ethics and Values in IP IP and ethics, positive and negative aspects of IPR, social responsibility, avoiding unethical practices, eco-responsibility–economic, social and environmental benefits of modern biotechnology. 5h Biostatistics

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General concepts, two-tail student t-test and paired sample t-test, two samples t-test, Wilcoxon rank-sum test, Mann-Whitney test, one-way analysis of variance, Kruskal-Wallis test, two-way analysis of variance, multiple comparison procedures in ANOVA: Fischer’s LSD test, Tukey’s studentized range test and Dunnett’s test. Non-linear regression: Introduction, iterative method. Correlation, linear regression, PCA and PLS. 20h Reading Material Recommended 1. Treece DJ. Managing Intellectual Capital: Organizational, Strategic and Policy Dimension. Oxford

University Press, England. Latest Edition. 2. Wadedhra BL. Law Relating to Patents, Trademarks, Copyright Design and Geographical Indications.

Universal Law Publishing, New Delhi. Latest Edition. 3. Bansal P. IPR Handbook for Pharma Students and Researchers, Pharma Book Syndicate, Hyderabad.

Latest Edition. 4. Copyright Protection in India [website: http:copyright.gov.in]. 5. Information on Orange Book [website: www.fda.gov/cder/ob/default.htm]. 6. World Trade Organization [website: www.wto.org]. 7. Trivedi PR. Encylcopedia of Intellectual Property Rights. Jnanada Prakashan, New Delhi. Latest Edition. 8. Arya P. P. and Yashpal, Research Methodology in Management, Deep and Deep publications Private

Limited, New Delhi. 9. Green and Tull : A research for marketing research decisions, PHI (P) Ltd. New Delhi. 10. Karishna Swami, Shiva Kumar & Mathirajan, Management Research Methodology, Pearson Education. 11. Hooda, R P, Statistics for Business and Economics, MacMillan India Limited, New Delhi. 12. Heinz, Kohler: Statistics for business and Economics, Harper Collins. 13. Lawrence B Morse: Statistics for business and economics, Harper Collins. 14. Levin, Richard I. & David S Rubin: Statistics for management PHI Delhi. MPH - 231: PHARMACOLOGY– IV

(CLINICAL AND REGULATORY PHARMACOLOGY)

4 Hours/week Max. Marks - 80 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. 1. Introduction to Clinical Pharmacology 10h Definition, scope and development of clinical pharmacology, role of pharmacist in healthcare system, prescription monitoring and rational use of drugs, essential drugs and national drug policy, pharmacoepidemiology, pharmacovigilance, patient counselling, medication errors and drug information systems. 2. Concepts of Pharmaceutical Care and its Implementation 4h Plan, components and challenges, communication and behavioural skills in clinical pharmacology practice. 3. Drug Therapy in Specialized Patient Populations 14h 3.1. Neonates: Special childhood diseases and their management, national immunization programmes, relevant paediatric management issues as dosages adjustment, pharmacokinetics of development stage and compliance. 3.2. Geriatrics: Pharmaceutical care plan based on age related physiological and pharmacokinetic / pharmacodynamic changes, compliance related issues. 3.3. Pregnancy and Lactation: Guidelines and principles of drug therapy during pregnancy and lactation. Management of hypertension, diabetes, epilepsy etc. during pregnancy. 4. Clinical Trials 20h 4.1. Requirements of clinical trials, Helsinki declaration, ethical and legal issues in clinical trials. 4.2. Design (placebo, multicentre clinical trials, randomization, blinding) and different phases of clinical trials (Phase 1 to 4), principles of controlled clinical trials.

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4.3. Protocol designing, CRF, patient informed consent, patient enrolment, inclusion and exclusion criteria, withdrawals and drop out, run-in period. 4.4. Clinical trial team, monitoring of clinical trial, report preparation, deviations in clinical trials. 4.5. Clinical data management. 5. Adverse Drug Reactions 6h Incidence, importance, surveillance and their monitoring, WHO ADR reporting programmes in India and drug interactions. Drug food interaction, Drug food-herb interaction. (6 Lectures) 6. National and International Guidelines and Drug Regulations and Recent Developments in Clinical Research 6h Good clinical practice, OSD guidelines, ICH guidelines, FDA/EMEA documentation preparation. Reading Material Recommended 1. Bennett PN and Brown MJ. Clinical Pharmacology. Churchill Livingstone, Edinburgh. Latest Edition. 2. Walker R and Edwards C. Clinical Pharmacy and Therapeutics. Churchill Livingstone, London. Latest Edition. 3. Shargel L, Mutnick AH, Souney PF and Swanson LN. Comprehensive Pharmacy Review. Wolters Kluwer Health / Lippincott William & Wilkins, New Delhi. Latest Edition. 4. Dipiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG and Posey LM, Eds. Pharmacotherapy: A Pathophysiologic Approach. McGraw-Hill, New York. Latest Edition. 5. Laurence DR. Clinical Pharmacology. Churchill Livingstone, London. Latest Edition. MPH - 232: PHARMACOLOGY-V

(CELLULAR AND MOLECULAR PHARMACOLOGY) 4 Hours/week Max. Marks - 80 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. The course content will equip the students with adequate knowledge of the molecular process occurring within cell and the possible Pharmacological interventions into those processes.

I Introduction to Molecular Biology and molecular genetics 15 h 1. Gene structure: Organization and elucidation of genetic code. 2. Gene expression: Expression systems (pro and eukaryotic), genetic elements that control gene

expression 3. Protein synthesis: Mechanisms of protein synthesis, initiation in eukaryotes, translation control and

post-translation events 4. Oncogenes and tumor suppressor genes. II Cellular signaling system 12 h 1. Receptor occupancy, communication between cells and their environment, role of G-proteins, cyclic

nucleotides, calcium and phosphatidyl inositol in cell signaling system. III Gene manipulations: 15 h

1. DNA replication: General, bacterial and eukaryotic DNA replication 2. Recombinant DNA technology: Principles, Processes (Gene Transfer Technology) and applications. 3. Gene cloning: Gene isolation, cloning vectors, enzymes used in molecular cloning, gene libraries and

screening, analysis of cloned DNA, PCR , LCR and RFLP techniques and their applications, IV Human genetics: 15 h

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1. Cytogenetic 2. Chromosomal aberration 3. Gene sequencing 4. DNA-based diagnosis of genetic diseases 5. Gene therapy and targeting 6. Antisense technology 7. Human genome project 8. Bio Ethics

V. Apoptosis: 1. Pharmacological and clinical implication 3 h Recommended Readings:

1 Molecular Biology of the Cell by Alberts B., Bray, D., Lewis, J., Raff M., Roberts, K and Watson, JD, 3rd edition.

2 Molecular Cell Biology By Lodish, H., Baltimore, D., Berk, A et al., 5th edition 3 Molecular Biology by Turner, PC., McLennan, AG., Bates, AD and White MRH 2nd edition. 4 Genes VIII by Lewin, B., (2004) 5 Pharmaceutical Biotechnology, by Crommelin, DJA and Sindelar RD (1997) 6 Recombinant DNA by Watson, JD., Gilman, M., et al., (1996) 7 Biopharmaceutical: Biochemistry and Biotechnology by Walsh, G., (1998)

MPH - 233: PHARMACOLOGY-VI

(RECENT ADVANCES IN PHARMACOLOGY) 4 Hours/week Max. Marks - 80 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus.

1. Pharmacological and clinical implications of Endogenous bioactive molecules such as

cytokinines, neuropeptide and their modulators, neurosteroids, nitric oxide, phosphodiesterase enzymes and protein kinase C, arachidonic acid metabolites, Platelet Activating Factor, Cyclo-oxygenase 1 and 2 regulators and their role in inflammation, reactive oxygen intermediates, antioxidants and their therapeutic applications. 16h

2. Pharmacology of Receptors:

Classification, cellular signaling systems, pharmacology of agonists and antagonists of the following receptor types: i) Adrenoceptors ii) Cholinergic iii) Serotonin receptors iv) Dopamine receptors v) GABA and benzodiazepine receptors vi) Histamine receptors vii) Excitatory amino acid receptors viii) Angiotensin receptors ix) Cannabinoid receptors x) Kinin receptor xi) Hormone receptors xii) Opoid receptor xiii) Glutamate Receptor xiv) Purinergic receptor 24h

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3. Ion Channels and their modulators: Classification and biology of ionic channels, pharmacology of substances which modulate the following cannels:

i) Calcium channels ii) Potassium channels iii) Sodium channels 14h

4. Basic concepts of Chronopharmacology and their implications to drug therapy 3h 5. Basic concept of high throughput screening 3h RECOMMENDED READINGS: 1) Annual reviews of Pharmacology and Toxicology

2) Annual reviews of Medicine

3) Trends in Pharmacological Sciences

4) Trends in Biochemical Sciences

5) Advances in Pharmacology

6) Advances in Drug Therapy

7) Drug Discovery Today

8) Receptor-based drug design, Paul Left, Marcel Dekker, Inc.

9) Drug Receptors & their Effectors

Edited by Nigel, J.M. Birdsall, MC Millan Publishers Ltd.

10) Receptor Classification :

The Integration of Operational, structural and Transductional Information.

D.G.Trist, P.P.A. Humphery, P.Left; N.P.Shankley- New York Academy of Sciences

11) Text Book of Receptor Pharmacology

John C. Foreman,Torben Johansen

12) Drug Receptors

H.P. Rang, University Park Press

MPH 234: PHARMACOLOGY PRACTICAL -II 12 Hours/week Max. Marks: 120

1. Practical based on clinical and regulatory pharmacology

2. Practical based on cellular and molecular pharmacology

a. Plasmid DNA Extraction

b. Restriction Enzyme Digestion. c. Ligation of Digested DNA d. Transformation of Bacterial Cells e. Genomic DNA Extraction f. PCR amplification g. Polyacrylamide Gel Electrophoresis h. Western Blotting.

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i. Southern Blotting 3. Practical based on receptor pharmacology

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INSTITUTE OF PHARMACEUTICAL SCIENCES, KURUKSHETRA UNIVERSITY KURUKSHETRA

Syllabus: M. Pharm. (Pharmacognosy and Phytochemistry) First Semester

MPH - 101: MODERN PHARMACEUTICAL AND ANALYTICAL TECHNIQUES 4 hours/week Max. Marks 80 Note: The paper setter will set 7 questions (First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus; three question from section A and one question from each section B, C and D); out of which the candidate will be required to attempt 5 questions in all and atleast one question from each section. All questions will carry equal marks. A. Pharmaceutical Chemistry (27h)

1. Infrared Spectroscopy (4h) Introduction, the infrared absorption process, the modes of vibrations, stretching and bending, bond properties and absorption trends, basics of instrumentation techniques, pharmaceutical applications.

2. Ultraviolet Spectroscopy (3h) Introduction, the nature of electronic excitation, the origin of uv band structure, principle of absorption spectroscopy, chromophore- σ→σ*, η→σ*, π→π* transitions, basics of instrumentation techniques, pharmaceutical applications.

3. Nuclear Magnetic Resonance Spectroscopy (4h) Introduction, nuclear spin states, nuclear magnetic moments, absorption of energy, the mechanism of resonance, chemical equivalence, spin-spin coupling, basics of instrumentation techniques, pharmaceutical applications.

4. Mass Spectrometry (5h) Basic principle and theory involved, basics of instrumentation techniques, pharmaceutical applications.

5. Thermal Analysis (7h) Introduction to various thermal methods of analysis, basic principles and theory, instrumentation and pharmaceutical applications of thermo gravimetric analysis (TGA), differential thermal analysis (DTA), differential scanning calorimetry (DSC) and microcalorimetry, different types of calorimeters and micro calorimeters, advantages of microcalorimetry over DSC.

6. Optical Rotatory Dispersion and Circular Dichroism (4h) Definition, theory and instrumentaton of ORD and CD. Cotton effect, Octant rule and its applications B. Pharmaceutics (13h)

1. Basic elements of Novel drug delivery systems. 2. Bioavailability and bioequivalence testing, significance of terminology, conduct of bioavailability

trials. 3. Introduction to validation of manufacturing facilities I.Q. / O.Q. and certification, preparation of

validation protocols. 4. Stability testing: Stress testing of drug substances, stability testing protocols, shelflife

determination, ICH guidelines.

C. Pharmacognosy (10h) Plant tissue culture: Conventional breeding v/s tissue culture, Applications of Plant tissue culture technique,Tissue culture media (composition & preparation), Preparation of explant, Sterilization techniques, Type of cultures, Protoplast technology and its applications, Immobilization techniques and their applications, Tissue culture as a technique to produce novel plants and hybrids, Factors affecting the production of secondary metabolites from tissue- culture.

D. Pharmacology (10h)

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Definition of bioassay, various types of bioassays, advantages and limitations of bioassays with suitable examples, Theory and application of radioimmunoassay and ELISA. Animal models for screening of anti-inflammatory, anti-convulsant, and anti-diabetic.

Reading Material Recommended 1. Silverstein RM and Webster FX. Spectrometric Identification of Organic Compounds. John Wiley and

Sons, New York. Latest Edition. 2. Pavia DL, Lampman GM and Kriz GS. Introduction to Spectroscopy. Harcourt College Publishers,

Orlando. Latest Edition. 3. Vogel HG and Vogel WH. Drug Discovery and Evaluation. Springer-Verlag, Berlin. Latest Edition. 4. Kulkarni SK. Handbook of Experimental Pharmacology. Vallabh Prakashan, New Delhi. Latest Edition. 5. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata. Latest Edition. MPH 102: MODERN PHARMACEUTICAL AND ANALYTICAL TECHNIQUES PRACTICAL 4 Hours/week Max. Marks: 80

Modern experiments having relevance to the topics covered under theory.

Reading Material Recommended 1. Indian Pharmacopoeia, Central Indian Pharmacopoeia Laboratory, Govt. of India, Ministry of Health &

Family Welfare, Ghaziabad, Latest Edition. 2. U. S. Pharmacopoeia – NF, The United States Pharmacopoeial Convention, Rockville, USA, Latest

Edition. 3. European Pharmacopoeia, Directorate for the Quality of Medicines of the Council of Europe

(EDQM), Strasbourg, Europe, Latest Edition. 4. British Pharmacopoeia, The Stationary Office on behalf of the Medicine Health Care Product

Regulatory Agency (MHRA), London, Latest Edition. 5. Mendham J, Denney RC, Barnes JD and Thomas M. Vogel’s Textbook of Quantitative Chemical

Analysis. Pearson Education Limited, Singapore. Latest Edition. 6. Silverstein RM and Webster FX. Spectrometric Identification of Organic Compounds. John Wiley and

Sons, New York. Latest Edition. 7. Vogel HG and Vogel WH. Drug Discovery and Evaluation. Springer-Verlag, Berlin. Latest Edition. 8.

Kulkarni SK. Handbook of Experimental Pharmacology. Vallabh Prakashan, New Delhi. Latest Edition. 9. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata. Latest Edition. MPH - 141: Pharmacognosy-I

(NATURAL PRODUCT DRUG DISCOVERY) 4 Hours/week Max. Marks - 80 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus.

1. Ethnopharmacognosy / Ethnomedicine, its concept, scope and importance. (5) 2. Drug Discovery From Natural Sources like Terrestrial Plants, Microorganisms, vertebrates/invertebrates

.(10h) 3. Marine Drugs/Products: Definition, present status, classification of important bioactive agents, their general

methods of isolation and purification (where reported), study of important bioactive agents including their chemistry and uses. (10 h)

4. Introduction, Classification and uses of Natural Bitters and Sweeteners. (15h) 5. Introduction, Classification and uses of Natural Pigments and colorants/dye yielding plants. (5h) 6. General introduction to High Throughput Screening in natural products (5 h) 7. Natural Pesticides and Insecticides. (5)

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8. Natural products having nutritional potentials. (5)

RECOMMENDED READINGS: 1. Bioactive Natural Products: Detection, Isolation, and Structural Determination; CRC Press. 2. Natural Product Chemistry at a Glance, Stephen P. Stanforth; Blackwell. 3. Medicinal Plants, Moshrafuddin Ahmed; Oxford & IBH publishing co. Pvt Ltd. 4. Herbal Drugs: Ethnomedicine to Modern Medicine; Springer 5. Herbal Combinations, Woodland Publishing, Rita Elkins Mh; Woodland Publishing. 6. Herbal Medicine: Trends and Traditions (A Comprehensive Sourcebook on the Preparation and Use

of Medicinal Plants), Charles W. Kane ; Publisher: Lincoln Town Press 7. Herbal Medicine: Biomolecular and Clinical Aspects; CRC Press. 8. Herbal Products: Toxicology and Clinical Pharmacology, Humana Press 9. Herbal Technology: Concepts & Approaches; M. Danial; Publisher: Satish Serial 10. Pharmacognosy, A. Roseline; MJP Publishers 11. Textbook of Pharmacognosy and Phytochemistry, Biren Shah, Elsevier. 12. Text Book of Pharmacognosy and Phytochemistry, Jarald, CBS. 13. Textbook Of Phytochemistry, Syed Aftab Iqbal; Discovery Publishing House Pvt Ltd.

MPH - 142: PHARMACOGNOSY-II (EXTRACTION AND ISOLATION OF HERBAL DRUGS)

4 Hours/Week Max. Marks - 80 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus.

1. Conventional extraction methods such as maceration, infusion, digestion, decoction, percolation, Soxhlet’s extraction etc. Various Steps involved in extraction of medicinal plants (5h)

2. Aqueous alcoholic extraction of medicinal and aromatic plants by fermentation for Ayurvedic dosages form (5h)

3. Introduction to novel methods of extraction such as solid phase micro-extraction, supercritical fluid extraction, Microwave-assisted extraction, Ultrasonic-assisted extraction and comparison with Conventional extraction methods (15h)

4. Extraction technique/procedures employed in the isolating essential oils from aromatic plants (5h) 5. General methods of extraction, isolation and analysis of phytoconstituents: Carbohydrates, alkaloids,

glycosides, and terpenoids (5h) 6. Introduction to bioassay-guided fractionation of phytoconstituents and its application. (5h) 7. Introduction and applications of various separation techniques in plant drug analysis: Open column

chromatography, TLC, HPTLC, HPLC, Droplet counter current chromatography, Vacuum liquid chromatography, Flash Chromatography, GC-MS etc. (20h)

Reading Material Recommended 1. Industrial Scale Natural Product Extraction by Hans-Jörg Bart, Stephan Pilz; Wiley 2. Solvent Extraction Principles and Practice, Rydberg Rydberg, Michael Cox; CRC Press. 3. Laboratory Handbook for the Fractionation of Natural Extracts, Peter Houghton, Peter J.

Houghton, Amala Raman; Springer MPH - 143: PHARMACOGNOSY-III

(STANDARDIZATION AND REGULATORY AFFAIRS OF HERBAL DRUGS) 4 Hours/Week Max. Marks – 80 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. 1. Standardization of herbal drugs/extracts as per WHO guidelines: (20h)

i) Physical, chemical, spectral and toxicological standardization

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ii) Qualitative and quantitative estimations exemplifying the methods of preparation of at least two standardized extracts

iii) Standardization of single drug and compound formulation iv) Importance of standardization and problems involved in the standardization of herbs

2. Standardization and extraction methods of herbal drugs: Aloe barbadensis, Andrographis paniculata, Artemisia annua, Boswellia serrata, Centella asiatica, Hypericum perforatum Terminalia arjuna, Tinospora cordifolia, Withania somnifera. (20h)

3. Quality assurance and Stability testing of Herbal Drugs: (08h) i) Indicative substances for quality assurance ii) GMP/GLP in herbal medicines. iii) Physical Quality Assurance iv) Stabilization methods ii) Validation of Analytical Procedures

4. Regulatory requirements for herbal medicines in India and USA. (07 h) 5. Pharmacovigilance for herbal formulations (05) Reading Material Recommended

12. Quality Control of Herbal drugs: an approach to evaluation of botanicals, Pulock K. Mukherjee, Horizons Publishers.

13. Legal regulations of complementary and alternative medicines in different countries, Pharmacogn Rev. 2012 Jul-Dec; 6(12): 154-160.

14. Standardization of Botanicals: Testing and Extraction Methods of Medicinal Herbs, Volume 1 and Volume 2. 15. GMP for Botanicals By: Prof. Dr. Robert Verpoorte and Dr. Pulok K. Mukherjee, Business Horizon. 16. Herbal Drug Industry by V.Rajpal and DPS Kohli, Business Horizon. 17. Indian Herbal Pharmacopoeia by: Indian Drug Manufacturers Association 18. Regulatory Roadmap for Herbal Medicines By: G. Sudesh Kumar, Business Horizon 19. Monographs and relevant review articles appearing in various Periodicals and Journals.

MPH 144: PHARMACOGNOSY PRACTICAL – I 12 Hours/week Max. Marks: 120 Modern experiments having relevance to the topics covered under theory of papers MPH – 141, 142, 143 including the following:

1. Preparation of herbarium. 2. Isolation of papain. 3. Isolation of pectin. 4. Isolation of natural dye anthocyanin. 5. Isolation of glycyrrhizin from Liquorice. 6. Isolation of total oleogum resins from Ginger. 7. Isolation of nicotine as nicotine picrate from Tobacco leaves. 8. Isolation of hesperidine from Orange peels. 9. Isolation of bererine from Berberis aristata. 10. Isolation of Rhein from rhizome of Rheum species. 11. Isolation of Piperine from Piper nigrum. 12. Isolation of Quinine from Cinchona bark. 13. Isolation of Menthol from Mentha species. 14. Isolation of Caffeine from Tea leaves 15. Isolation of Carvone content of Umbelliferous fruits. 16. Isolation of Starch and successive isolation of amylase and amylopectin from potato. 17. Determination of Anthracene derivatives in Senna by spectrophotometric method. 18. Thin Layer Chromatography/ Paper Chromatography identification of phytoconstituents. 19. WHO methods of standardization of Herbal drugs:

i) Determination of Swelling index. ii) Determination of Foaming index. iii) Determination of Ash value. iv) Determination of Extractable matter. v) Determination of Volatile oil. vi) Determination of Moisture Content. vii) Determination of Haemolytic activity.

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viii) Determination of Tannins. ix) Determination of Bitterness value. x) Determination of Leaf constants. xi) Determination of Foreign organic matter.

20. Phytochemical screening of active constituents obtained from plants. Recommended Readings:

1. Practical Evaluation of Phytopharmaceuticals – Brain and Turner, Wright Scientechnica 2. Modern Methods of Plant Analysis-Peach and Tracy, Springer Verlag 3. Different relevant Pharmacopoeias Like IP, BP, USP, IHP, etc. current editions. 4. Practical Pharmacognosy, C.K. Kokate, Vallabh Prakashan 5. Practical Pharmacognosy – K.R. Khandlwal, Nirali Prakashan, Pune. 6. Herbal Drug Technology, S.S. Agrawal, M. Paridhavi, Universities Press 7. Quality Control of Herbal drugs: an approach to evaluation of botanicals, Pulock K. Mukherjee, Horizons

Publishers. Second Semester MPH – 201: BIOSTATISTICS AND INTELLECTUAL PROPERTY RIGHTS 4 Hours/week Max. Marks - 80 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. Intellectual Property Rights 1. Intellectual Property Concepts and fundamentals: The emergence and growth of the concepts regarding intellectual property (IP), intellectual property protection (IPP) and intellectual property rights (IPR); economic importance, mechanism for protection of intellectual property - patents, copyright, trademarks; role of IP in pharmaceutical industry; global ramifications and financial implications. (10h) 2. Trade Related Aspects of Intellectual Property Rights Intellectual property and international trade, concept behind WTO (World Trade Organization), WIPO (World Intellectual Property Organization), GATT (General Agreement on Tariff and Trade), TRIPs (Trade Related Intellectual Property Rights),TRIMS (Trade Related Investment Measures) and GATS (General Agreement on Trades in Services), status in India and other developing countries, case studies and examples, TRIPS issues on herbal drugs. (10h) 3. Nuts and Bolts of Patenting Copyright and trade mark protection, criteria for patentability, Indian patent act. 1970: WTO and modifications under TRIPS, filing of a patent application, precautions before patenting-disclosures/non-disclosures, publication-article/ thesis, prior art search – published patents search, internet search patent sites, specialized service search requests, costs, patent application forms and guidelines, fee structure, time frames, jurisdiction aspects, types of patent application - provisional, nonprovisional, PCT and convention patent applications, international patenting requirement procedures and costs. Patent infringement: Meaning, scope, litigation, drug related patents infringements, case studies and examples, patenting by research students. Trademarks legislation and registration system in India - an introduction, meaning of trademark, criteria for eligibility, filling application for trademark registration, trade secrets - scope modalities and protection case studies. (15 h) 4. Ethics and Values in IP IP and ethics, positive and negative aspects of IPR, social responsibility, avoiding unethical practices, eco-responsibility–economic, social and environmental benefits of modern biotechnology. (5 h) Biostatistics General concepts, two-tail student t-test and paired sample t-test, two samples t-test, Wilcoxon rank-sum test, Mann-Whitney test, one-way analysis of variance, Kruskal-Wallis test, two-way analysis of variance, multiple comparison procedures in ANOVA: Fischer’s LSD test, Tukey’s studentized range test and Dunnett’s test. Non-linear regression: Introduction, iterative method. Correlation, linear regression, PCA and PLS. (20 h) Reading Material Recommended

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1. Treece DJ. Managing Intellectual Capital: Organizational, Strategic and Policy Dimension. Oxford University Press, England. Latest Edition.

2. Wadedhra BL. Law Relating to Patents, Trademarks, Copyright Design and Geographical Indications. Universal Law Publishing, New Delhi. Latest Edition.

3. Bansal P. IPR Handbook for Pharma Students and Researchers, Pharma Book Syndicate, Hyderabad. Latest Edition.

4. Copyright Protection in India [website: http:copyright.gov.in]. 5. Information on Orange Book [website: www.fda.gov/cder/ob/default.htm]. 6. World Trade Organization [website: www.wto.org]. 7. Trivedi PR. Encylcopedia of Intellectual Property Rights. Jnanada Prakashan, New Delhi. Latest Edition. 8. Arya P. P. and Yashpal, Research Methodology in Management, Deep and Deep publications Private

Limited, New Delhi. 9. Green and Tull : A research for marketing research decisions, PHI (P) Ltd. New Delhi. 10. Karishna Swami, Shiva Kumar & Mathirajan, Management Research Methodology, Pearson Education. 11. Hooda, R P, Statistics for Business and Economics, MacMillan India Limited, New Delhi. 12. Heinz, Kohler: Statistics for business and Economics, Harper Collins. 13. Lawrence B Morse: Statistics for business and economics, Harper Collins. 14. Levin, Richard I. & David S Rubin: Statistics for management PHI Delhi. MPH - 241: PHARMACOGNOSY-IV

(CHARACTERIZATION OF PHYTOCONSTITUENTS)

4 Hours/week Max. Marks - 80 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. 1. General methods of investigation of biogenetic pathways. (5 h) 2. Extraction, Isolation and characterization by Chromatographic and spectral means of following active

principles: (10 h) i) Atropine ii) Caffeine iii) Piperine iv) Ephedrine v) Ergotamine vi) Quinine

3. Chemistry and structure elucidation of the following categories: (20 h) i) Alkaloids: Morphine, Reserpine. ii) Steroids: Cholesterol, Digitoxin iii) Flavonoids: Quercitin iv) Terpenoids: Citral, menthol

4. Stereochemistry of natural products: Introduction, types of stereoisomerism with suitable examples and special emphasis on tropines, monosacchrides, camphor, menthol and neomenthol. (15 h)

5. Review of various phytoconstituents used as prototypes for therapeutically active Constituents. (5h) 6. Natural pigments: occurrence, general methods of isolation and characterization of anthocyanins and

carotenoids with special emphasis on cyanin and beta carotene. (5 h)

Reading Material Recommended 1. Trivedi PR. Encylcopedia of Intellectual Property Rights. Jnanada Prakashan, New Delhi. Latest Edition.

Organic Chemistry: Stereochemistry and the chemistry of natural products,Vol.-II, I.L. Finar. 2. Analytical profiles of drug substances, K. Florey, Academic press. 3. Recent progress in medicinal plants: Phytochemistry & Pharmacology, V.K. Singh etal, Studium press, USA 4. Pharmacognosy, Ed. W.C. Evans Gopsons Papers Limited, Noida. 5. Structure Elucidation of Natural Products by Mass Spectroscopy- Vol I & II, H. Budzikiewiez, C.Djerassic and

D.H. Williams

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6. Tables of Spectral Data for Structural Determination of Organic Compounds, E. Pretsch, T,Clerc, J. Seibl and W. Simon

7. Heterocyclic Chemistry, Albert 8. Biogenesis of natural Compounds, Bernfeld 9. An Introduction to the Chemistry of Terpenoids and Steroids, Templeton 10. Organic Chemistry of secondary Plant Metabolism, Geissman and Crout 11. Chemistry of the Alkaloids, Pelletier 12. The Chemistry of the Natural Products, Butterworths. 13. Pharmacogonosy and Pharmacobiotechnology : J.E. Robbers, M.K. Speedie and V.E. Tyler. 14. Modern Methods of Plant analysis, Peach and Tracey, All Volumes, Springer-Verlag 15. Practical Pharmacognosy, C.K. Kokate, Vallabh Prakashan 16. Practical Organic Chemistry, F.G.Mann and B.C.Saunders 17. Practical evaluation of phytopharmaceuticals, Brain and Turner, Wright-Scientechnica. 18. Phytochemical methods, Harborne, J.B., Champman Hall. 19. Screening Methods in Pharmacology Turner, Academic Press 20. Different relevant pharmacopoeias, Current editions 21. Isolation and Identification of Drugs, Clark E.C.G, The Pharmaceutical Press, London. 22. Vogel’s Text Book of Practical Organic Chemistry. 23. Applications of Absorption Spectroscopy, John R.Dyer 24. Organic Chemistry, Morrison & Boyd 25. Experimental Methods in Organic Chemistry, Moore and Dalrymple 26. Stereochemistry- R.S. Kalsi. 27. G.A. Cordell, Introduction to Alkaloids, John Wiley and Sons, New York. 28. M.L. Wickery and B. Wickery, Secondary Plant Metabolism McMillan Press Ltd. London. 29. L.F. Fieser and M. Fieser, Steroids, Reinhold Publishing Co. New York. 30. K.B.G. Torsell, Natural Products Chemistry, John Wiley and Sons, NewYork. 31. J.B. Harborne, Phytochemical Methods, Chapman and Hall, London 32. Burger’s Medicinal Chemistry and Drug Discovery, Vol. I. Principle and 33. Practice, 5th, Edition, John Wiley Sons, New York. 34. Natural Products for Plants by Kaufmann, CRC Press New York. 35. Nakanishi K (1977). Chemistry of Natural Products, Kodansha Book Publishing Company, Osaka (Japan). 36. Medicinal Natural Products, Paul M. Dewick, John Wiley & Sons Ltd. 37. Chemistry of Natural Products, S. V. Bhat, B.A.Nagasampagi, M. Sivakumar, Narosa Publishing House. 38. The Phytochemistry of Herbs By: Lisa Ganora, Business Horizon

MPH - 242: PHARMACOGNOSY-V

(HERBAL DRUGS DEVELOPMENT AND FORMULATION)

4 Hours/week Max. Marks – 80 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus.

1. Herbal product development: (30 h)

i) Liquid orals, tablets, capsules and dermatologic. ii) Methods involved in monoherbal and polyherbal formulations with their merits and demerits. iii) Excipients used in herbal formulations. iv) Compatibility studies v) Stability studies vi) Phytoequivalence & pharmaceutical equivalence vii) Quality control of finished herbal medicinal products viii) Packaging and Labelling of finished products

2. Herbal cosmetics: (15 h)

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Identification, collection and chemical nature of the natural products used in: Hair care, dandruff, dyeing, Skin care, anti-wrinkles & anti-aging, Teeth care

3. Herbs as health food: (15 h)

i) Antioxidants ii) Prebiotics & Probiotics iii) Polyunsaturated fatty acids iv) Dietary supplements

Reading Material Recommended

1. Herbal Drugs Industry- R.D. Choudhry 2. Text Book of Pharmacognosy Wallis, CBS Publishers 3. Text Book of Pharmacognosy – Trease & Evans 4. Pharmacopoeial Standards for Ayurvedic drugs, C.C.A.R.I., New Delhi 5. Remington -The Science and Practice of Pharmacy - Vol. I & II, A.R. Gennard 6. Ayurvedic Formulary of India 7. All Pharmacopoeias relevant, current editions. 8. Herbal Medicines by Jonne Bernes, Pharmaceutical Press, London. 9. Medicinal Plants in Skincare by Sushil Kumar, CIMAP, Lucknow. 10. Tyler’s Herbs of Choice: The Therapeutic uses of Phytomedicine, James E. Robbers, Varoo E. Tyler, CBS

Publishers & Distributors 11. Formulating, Packaging and Marketing of Natural Cosmetic Products, Lambros Kromidas, Nava

Dayan; Wiley

MPH - 243: PHARMACOGNOSY-VI (ADVANCED PHARMACOGNOSY)

4 Hours/week Max. Marks – 80 Note: The paper setter will set 7 questions, out of which the candidate will be required to attempt 5 questions in all. All questions will carry equal marks. First question shall be compulsory and consists of sub-parts of 1 or 2 marks each from the whole syllabus. 1. Study of various models used in biological Evaluation of herbal drugs for following categories:

(20 h) i) Anti-inflammatory, ii) Antihyperlipidemic, iii) Anticancer, iv) Antidiabetic, v) Hepatoprotective, vi) Adaptogenic and immunomodulating, vii) Antimalarial,

viii) Antifertility 2. Pharmacognostic characterstics, chemical constituents and pharmacological basis of therapeutic uses of the

following plants: (20 h) i) Hepatoprotective plants: Andrographis paniculata, Glycyrrhiza glabra, Picrorrhiza,

Silybum marianum and Swertia chirata. ii) Anti inflammatory plants: Aesculus hippocastanum, Boswellia serrata,

Commiphora mukul and Curcuma longa. iii) Antidiabitic plants: Allium cepa, Azadirachta indica, Gymnema sylvestris, Momordica charantia,

and Trigonella foenum graecum. iv) Plants used in cardiovascular disorders: Digitalis, Terminalia arjuna, Thevetia nerrifolia and Viscum

album v) Antiviral plants: Echinaceae purpurea, Sambucus nigra, Saponaria officinalis,

Rhizophora species and Thuja occidentalis. vi) Plants used as adaptogens and immunomodulators: Allium sativum, Asparagus racemosus,

Ocimum sanctum, Panax ginseng, Phyllanthus emblica, Tinospora cordifolia and Withania somnifera.

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vii) Anticancer drugs: Camptotheca acuminata, Catharanthus roseus, Podophyllum species and Taxus species 3. Role of natural products in “Neglected Diseases” (Dengue, protozoal diseases including

leishmaniasis, trypanosomiasis, schistosomiasis, tuberculosis, leprosy). (7 h) 4. Pharmaceutical aids: Profile for manufacture of papain, pectin, Pharmaceutical gums, starch, absorbent cotton and gelatin (7h) 5. Plant derived polymers used in drug delivery (6h)

Recommended Readings:

1. Vogel H.G. and Vogel W.H. Drug Discovery and Evaluation, Springer Verlag, Berlin Herideleberg. 2. Ghosh M.N. Fundamentals of Experimental Pharmacology, Scientific Book Agency, Calcutta 3. Turner R.A Screening Methods in Pharmacology, Vol. I & II, Academic Press, New York & London. 4. Lawrence D.R. and Bacharach, AL. Evaluation of drug activities: Pharmacometrics, Academic press, 'London. 5. Malafaya, P.B.; Silva, G.A.; Reis, R.L. Natural-origin polymers as carriers and scaffolds for biomolecules and

cell delivery in tissue engineering applications. Adv. Drug Deliv. Rev. 2007, 59,207-233. 6. Shirwaikar, A.; Shirwaikar, A.; Prabu, S.L.; Kumar, G.A. Herbal excipients in novel drug delivery systems.

Indian J. Pharm. Sci. 2008, 70, 415-422 7. Polymeric Plant-derived Excipients in Drug Delivery Molecules 2009, 14, 2602-2620;

doi:10.3390/molecules14072602 8. Clinically Important Plants of Ayurveda by FRLHT, Business Horizon 9. Colour Atlas of Medicinal Plants by Narayan Das Prajapati and Dr. S. S. Purohit, Business Horizon 10. Database on Medicinal plants used in Ayurveda Vol 1 to Vol. 6. By Central council for researchin

ayurveda 11. Journal of Ethnopharmacology 12. Phytomedicine 13. Planta Medica 14. Phytotherapy Research

MPH – 244: PHARMACOGNOSY PRACTICAL – IV 12 Hours/week Max. Marks – 120

1. Study of UV-Visible and IR spectral data of Sennoside, rutin, vasicine, curcumin, atropine, ephedrine, aloe-emodin, brucine, ellegic acid, diosgenin, caffeine, cholesterol, reserpine, ursolic acid, quinine.

2. Solubility, melting point, optical rotation of the above mentioned compounds. 3. Estimation of phenolic contents. 4. Estimation of aldehyde contents. 5. Estimation of Total triterpenic acids in Boswellia serrata. 6. Estimation of Andrographolides from Andrographis paniculata. 7. Determination of Ascorbic acid (Vitamin C) by UV. Spectroscopic method in crude drugs. 8. Determination of Hyoscymine/Hyoscine in Datura species by UV. Spectroscopic method. 9. Quantitative estimation of Reserpine in Rauwolfia serpentina by HPLC method. 10. Quantitative estimation of Quinine in Cinchona bark by HPLC method. 11. HPTLC analysis of herbal extracts. 12. Evaluation of herbal preparations. 13. Preparation of explants, Surface sterilization, development of callus for the production of phytoconstituents in

Plant tissue culture technique. 14. Exercises on interpretation of a known compounds of Natural origin by using spectroscopic data (IR, NMR &

MASS)