University: Alexandria Faculty: Medicine Programme ...€¦ · pharmacokinetics and...

الهيئة القومية لضمان جودة التعليم واالعتماد

University: Alexandria

Faculty: Medicine

Programme Specifications

(Academic year: 2015/2016 )

A. Basic Information:

1. Program title: MD degree in clinical pharmacology

2. Department(s) offering the program: Department of clinical pharmacology

3. Date of program specifications approval: /1 /2016

B. Professional Information

1- Program Aims

By the end of the program the candidate will be able to

1.1 Understand the fundamental information and principles underlying the use of pharmacological agents.

1.2 Conduct appropriate medical research aiming at improving the quality of patient care through optimal

medication management based on sound pharmaco-therapeutic principles

1.3 Apply analytical and critical methods when dealing with medical problems.

1.4 Identify pharmacological and medical problems and suggest innovative solutions.

1.5 Use technological tools needed in his practice perfectly.

1.6 Communicate and lead team in systematic professional manner.

1.7 Commit to continuous self-development and transfer of his medical experience

1.8 Develop the ability to critically review the scientific literature, critically analyze information, synthesize

and summarize conclusions

3- Benchmarks:

3.1 Department of Pharmacology University of Oxford (http://www.pharm.ox.ac.uk/)

3.2 Department of Clinical Pharmacology. Medical University of Vienna

(http://klpharm.meduniwien.ac.at/)

3.3 American board of clinical pharmacology http://www.abcp.net/instructions.pdf

3.4 The Irish Committee on Higher Medical Training Curriculum For Higher Specialist Training In

Clinical Pharmacology. October, 2002.

http://www.rcpi.ie/EducationAndTraining/HMT%20%20Specialties%20Library/ICHMT%20-

%20Clinical%20Pharmacology%20Therapeutics%20-%20October%202002.pdf

3.5 Specialty training curriculum for clinical pharmacology And therapeutic by Joint Royal Colleges Of

Physicians Training Board-UK; May 200

http://www.pmetb.org.uk/fileadmin/user/QA/Curricula/Approved_curricula/CLINICAL_PHARMACOLO

GY_AND_THERAPEUTICS/CPT_3_Jul_07_Curr_0010.pdf

http://klpharm.meduniwien.ac.at/

http://www.abcp.net/instructions.pdf

http://www.rcpi.ie/EducationAndTraining/HMT%20%20Specialties%20Library/ICHMT%20-%20Clinical%20Pharmacology%20Therapeutics%20-%20October%202002.pdf

http://www.rcpi.ie/EducationAndTraining/HMT%20%20Specialties%20Library/ICHMT%20-%20Clinical%20Pharmacology%20Therapeutics%20-%20October%202002.pdf

http://www.pmetb.org.uk/fileadmin/user/QA/Curricula/Approved_curricula/CLINICAL_PHARMACOLOGY_AND_THERAPEUTICS/CPT_3_Jul_07_Curr_0010.pdf

http://www.pmetb.org.uk/fileadmin/user/QA/Curricula/Approved_curricula/CLINICAL_PHARMACOLOGY_AND_THERAPEUTICS/CPT_3_Jul_07_Curr_0010.pdf


Academic

Reference

Standards

ILOs

A. Knowledge and

understanding

A1. Discuss the pharmacology and possible effects of a

drug and integrate other disciplines with clinical

pharmacology.

A2. Review the pharmacodynamic and pharmacokinetic

concepts that will help in understanding basic drug

actions.

A3. Recognize the essential basics of pharmacological

research

A4. List the available targets of drug action

A5. Describe the characteristic specification of each

target

A6. Classify each target to different subcategories and

superfamilies that have been so far enrolled

A7. Identify linking signaling cascade of each target and

potential sites where a drug can possibly intervene

starting at cell surface down to nuclear modulation and

gene expression or repression

A8. Describe the final outcome of modulating the

different selected targets in terms of survival and death

A9. Recognize the importance of dose adjustment of

some antimicrobial drugs

A10. Evaluate the importance of drug monitoring of

certain drugs

A11. Assess the plasma level of certain

immunosuppressant drugs

A12. Discuss the pharmacokinetics of drugs with

narrow therapeutic index

A13. Distinguish Phase I Clinical Studies

a.14 Describe Pharmacokinetic and Pharmacodynamic

Considerations in the Development of Biotechnology

Products and Large M

olecules

A15 Distinguish Design of Clinical Development

Programs

a.16 Distinguish Role of the Administration (e.g. FDA)

in Guiding Drug Development

a.17Distinguish clinical applications of Drug Discovery

and development

A18. Design a clinical trial, collect data, analyze and


interpret results.

A19. Review recent guidelines in management of

common diseases

A20. Understand concept of drug safety

A21. Recognize adverse drug reactions

A22. Recognize glossary of terms used in

Pharmacovigilance

A23 Recognize recent updates in measuring costs and

sensitivity analysis

A24. Discuss toxicity tests

A25. Discuss applicable lines of management in drug

poisoning

A26. Discuss drug teratogens.

A27. Discuss drug related carcinogenesis

A28 Identify patient-reported health outcomes and

health-related quality of life measures.

A29. Review pharmacokinetic and pharmacodynamics

of anticancer drugs

A30. Understand appropriate pharmacotherapeutic

regimens in cardiovascular diseases in critically ill

patients

A31. Recognize specific problems of prescribing for

critically ill cardiac patient

A32. Recognize guidelines for managing critically ill

cardiac patient

A33. Recognize Basic immunologic Structure and

Function

A34. Recognize recent advances in Immunodeficiency

diseases

A35. Discuss Recombinant Proteins used in

Immunotherapy

A36. Discuss the drugs used in immunosuppressive

therapy

A37. Discuss the diagnosis and management of Allergic

diseases

A38. Discuss the Disease-modifying antirheumatic

drugs (DMARDs)

A39. Discuss Autoimmune Diseases

A40. Discuss the role of drugs in Transplantation

immunology

A41. Discuss in details types, preparations, toxicities of

active principles in herbal medicinal plants

B. Intellectual B1. Evaluate and provide drug information


skills B2. Formulate evidence-based treatment strategies for

important emergency situations

B3. Correlate the action of drugs on their targets to their

abilities to achieve a specific therapeutic outcome

B4. Predict the possibility of maximizing drug benefits

and minimizing adverse effects based on the acquired

knowledge linked to the studied signaling cascades

B5. Analyze areas of signaling cross talk where a single

drug can act instead of several drugs

B6. Allocate potential signaling molecules that could be

a target for new drug development

B7. Suggest a new targets where drugs can be used in

regenerative therapy versus those that can be eliminate

undesirable cell lines

B8. Design the therapeutic regimen of drugs depending

on the desired steady state plasma level

B9. Design Phase I Clinical Studies

B10. Apply Pharmacokinetic and Pharmacodynamic

Considerations in the Development of Biotechnology

Products and Large Molecules

B11. Construct Design of Clinical Development

Programs

B12. Construct Role of the Administration (e.g. FDA) in

Guiding Drug Development

b.13 Criticize clinical applications of Drug Discovery

and development

B14. Assess the presence or absence of significant

difference between different groups of the clinical trial,

using the appropriate statistical test

B15. Critically analyses papers

B16. Formulate evidence-based treatment strategies for

important clinical situations.

B17. Choose tools, techniques and methodologies in

dug safety evaluation

B18. Assess impact of adverse drug reactions on

adherence of patients to drugs

B19. Evaluate principal methodological challenges in

the reporting, analysis and interpretation of safety data

in clinical trials

B20. Calculation of average costs

B21- Share in six studies

B22. Explain toxicokinetics

B23. Choose alternative drugs to avoid potential


drug interactions.

B24 Apply the health outcomes and health-related

quality of life measures to pharmacotherapy.

B25 Analyze relevant information to determine drug

therapy problems, urgency, and priority for a given

clinical situation

B26. Apply the standards of practice for clinical

pharmacology to the critical care practice environment

using a standard process of care.

B27. Identify the best practice patterns to facilitate care

of the critically ill cardiac patient

B28. Choose suitable drugs for treatment of

immunological diseases .

B29. Choose alternative drugs to avoid potential drug

interactions

B30 Use evidence based data to assess the proper use of

herbal preparations

C. Professional

skills

C1. Add to the practice of the specialty and research

through creativity & innovation

C2. Assessment of drug regimens in different clinical

situations in the hospitalized patients

C3. Criticize specific drugs in specific situations

C4. Use computer programs to assess the level of

significance between different groups of a study

C5. Implement drug safety on rational drug use

C7. Monitor adverse drug reactions

C8 Acquire the technical skills (e.g. developing medical

decision trees

C9. Interpret images/ diagram Social/ethical skills (e.g.

interpretation of results at the population level,

understanding of ethical issues)

C10. Acquire personal/professional skills (e.g.

functioning within an organization

C11. Apply recent advances in methodology and

laboratory technology in drug research and clinical

investigations.

D. General and

transferrable

D1. Hold skills to critically evaluate evidence presented


skills by publications

D2. Acquiring new communication skills in designing

and delivering talks and lectures

D3. Train in team working

D4. Retreive methods for data search and information

analysis

D5. Recognize tools for critique and peer reviewing

D6. Communicate and share ideas with professors to

Use the computer aided decision making from drug

discovery in pharmacoeconomic

D7 Communicate and collaborate within a team

Application level

D8. Participate in Conceptualization level (e.g. one can

develop a new decision tree)

D9. Within a team design a research project done in

Alexandria Faculty Medicine about pharmacoeconomic

of neuropathic pain killers, antidiabetic,

antihypertensive

D10. Share in improving the quality of practice and

patient care in Alexandria

D11. Share in activities of (ISPOR= International

Society for Pharmacoeconomics and Outcome research)

D12. Communicate and share ideas with professors to

Use the computer aided evidence based data regarding

herbs

D13. Communicate and collaborate within a team able

to understand and refined food-drug herb interaction or

allergy

D14. Participate in experimental studies

D15. Within a team design a research project done in


Alexandria Faculty Medicine regarding herbal or

homeopathic modulation of neuropathic pain killers,

antidiabetic, antihypertensive

D16. Share in completion of a national research in

Alexandria Somuaha hospital

E. Attitudes and

ethical

behavior

E1. Apply regulations and ethics that govern physicians

in promotion and detailing of drugs.

E2. Obtain consent that is truly informed

E3. Manage special challenges of performing clinical

research in vulnerable populations

E4. Manage confusion of roles in academic medical

centers and problems with duplicative, interactive, or

conflicting drug treatment plans

E5. Integrate with other members of medical team to

provide the patients the appropriate medical care

E6. Apply regulations and ethics during laboratory work

on experimental animals

E7. Show respect to professors, colleagues, other

members of medical team and to patients.


Matrix of Program ILOs/Courses ILO

Course

A1 A2

A3

A4-7

A8

A9 -12

A13-17

A18 A19

A20- 22

A23 A24-27

A28

A29.

A30-32

A33-40

A41

Advanced Internal medicine × × ×

Pharmacology Updates I × × ×

Pharmacology Updates II × × Advanced clinical

pharmacokinetics and

pharmacodynamics

× × ×

Advanced Drug Discovery

and development. ×

Biostatistics and data

management in clinical trials ×

Advanced

Neuropharmacology × × ×

Advanced Pharmacotherapy. × × ×

Drug Safety. × Pharmacoeconomic

Applications. ×

Advanced toxicokinetics &

Drug poisoning ×

Health Outcomes and

Health-Related Quality of

Life.

×

Oncology for Clinical

pharmacology. × × × ×

Acute Care Cardiology ×

Clinical Immunology ×

Herbal use in therapy ×


ILO

Course

B1 B2

B3-4

B5-7

B8 B9-13

B14-15

B16 B17-19-

B20-21

B22- 23

B24 B25

B26-27

B28-29

B30


Pharmacology Updates I × × ×

Pharmacology Updates II × × Advanced clinical


pharmacodynamics

×


and development. ×



Advanced

Neuropharmacology × ×



Applications. ×


Drug poisoning ×

Health Outcomes and


Life.

×


pharmacology. ×




ILO

Course

C1 C2 C3 C4 C5-7 C8-10

C11- C12 C13-14


Pharmacology Updates I × ×

Pharmacology Updates II Advanced clinical


pharmacodynamics

×


and development. ×



Advanced

Neuropharmacology × × ×

Advanced Pharmacotherapy. × × × ×


Applications. ×


Drug poisoning × ×


Health Outcomes and


Life.

×


pharmacology. ×




ILO

Course

D1-

D2-

D3 D4 D5 D6

D7

D8-

D9-11

D12-13

D14 D15-16

Advanced Internal medicine × × × × ×

Pharmacology Updates I × × × × Pharmacology Updates II × × × ×

Advanced clinical pharmacokinetics and pharmacodynamics × × × × ×

Advanced Drug Discovery and development. ×

Biostatistics and data management in clinical trials ×

Advanced Neuropharmacology × × ×


Drug Safety. ×

Pharmacoeconomic Applications. × × × ×

Advanced toxicokinetics & Drug poisoning ×

Health Outcomes and Health-Related Quality of Life. × × ×

Oncology for Clinical pharmacology. ×



Herbal use in therapy × × ×


ILO

Course

E1- E2 E3

E4 -E5 E6 -E7

Advanced Internal medicine × × × × Pharmacology Updates I × × × ×

Pharmacology Updates II ×

Advanced clinical pharmacokinetics and pharmacodynamics × × ×

Advanced Drug Discovery and development. × Biostatistics and data management in clinical trials ×

Advanced Neuropharmacology × × × × ×

Advanced Pharmacotherapy. × × × × × ×

Drug Safety. × Pharmacoeconomic Applications. × × × ×

Advanced toxicokinetics & Drug poisoning × × × × Health Outcomes and Health-Related Quality of Life. ×

Oncology for Clinical pharmacology. ×




5- Curriculum Structure and Contents:

5.1 Programme duration: 40 credit hours

5.2 Programme structure: …………………………………………………………..

C. Programme courses:

A. Obligatory:

Course Code Course Title Number No of Hours/Week


of Units Lectures Practical Clinical

051509060 Advanced Internal medicine 2 1 1

052409060 Oncology for Clinical

pharmacology. 2 1 1

050209060 Acute Care Cardiology 1 0.5 0.5

05060901 Pharmacology Updates I 3 2 1

05060902 Pharmacology Updates II 3 3

05060903 Advanced clinical


pharmacodynamics

2 1 1

05060904 Advanced Drug Discovery and

development. 3 2 1

05060905 Biostatistics and data

management in clinical trials 1 1

05060906 Advanced Neuropharmacology 2 1 1

05060907 Advanced Pharmacotherapy. 4 2 2

05060908 Drug Safety. 1 1

05060909 Pharmacoeconomic

Applications. 2 1 1

05060910 Advanced toxicokinetics &

Drug poisoning 3 2 1

05060911 Health Outcomes and Health-

Related Quality of Life. 1 1

05060912 Clinical Immunology 1 0.5 0.5

05060913 Herbal use in therapy 1 0.5 0.5

6- Curricular Contents:

Advanced Internal medicine

Code Course credit hours 2 Pre-requisites

051509060 Theoretical 1 Practical 1

Students taking this course examine how drugs work to attack various diseases including

neurological, nephrological, ENT, ophthalmic and dermatological diseases. They study commonly

prescribed medications, learning what they do, what side effects are possible and which drugs can't

be mixed. The class discusses reasons to use drugs to treat a condition even when the side effects

could be bad for the patient. The course also covers the problem of people developing immunity to a

drug or set of drugs.

Oncology for Clinical pharmacology.



By the end of this course, the student is supposed to have the proper knowledge and understanding

about the pathogenesis and criteria of carcinogenesis, the common carcinogens. He should have

detailed information about anti-neoplastic agents, their mechanisms of action, therapeutic uses,

adverse drug reactions and contra-indications. Updated information about guidelines for treatment of


common neoplastic diseases will be discussed in this course

Acute Care Cardiology


050209060 Theoretical 0.5 Practical 0.5

The Course Aims is to Gain advanced knowledge in optimizing use of medications for critically ill

cardiac patients and provide advanced clinical training in the areas of critical care pharmacotherapy to

develop independent problem-solving skills . This includes the establishment of a firm knowledge

base in cardiovascular pharmacology. The course will provide an integrated approach to critical

cardiovascular medicine and focus on applying scientific principles to direct patient care.

Pharmacology Updates -I


05060901 Theoretical 3 Practical

The course is designed to provide graduate students with the skills of research proposal, Appraise the

role of cloning in drug discovery, Underline the potential applications of nanotechnology in

pharmacology, and to explain in depth the molecular level of drug action in the field of cellular

calcium regulation, oxidants/antioxidant balance and stem cell therapy

Pharmacology Updates II


05060902 Theoretical 2 Clinical 1

This course is intended for the recognition of the different possible targets of drug action. It helps to

specify the level along any of the signaling cascade where a drug can possibly intervene to positively

or negatively achieve a beneficial therapeutic outcome. It further encourages selection between

similar group of drugs in light of their specificity and selectivity to a specified target. It will also

permit extrapolation of acquired data to new areas that can be targeted and open genuine avenues for

approaching such areas

Advanced clinical pharmacokinetics and pharmacodynamics



This course is intended to give advanced knowledge and application in clinical pharmacology.

Understanding the importance of drug monitoring. Discuss the role of dose adjustment for certain

drugs to improve patient treatment


Advanced Drug Discovery and development



Acquire advanced knowledge and apply recent techniques that help in exploring Drug discovery and

Development, in light of new and Novel criteria Targeted Drug Discovery and Development aiming

to reach the best Innovative Translational Strategies to Discover & Develop Drugs

Biostatistics and data management in clinical trials


05060905 Theoretical 1 Clinical

By the end of this course The candidates will be able to Design a clinical trial, collect data, analyze

and interpret results, Use evidence based medicine.,Critically analyses papers regarding rationale,

cogen.cy, experimental design, analytical methodology, method of analysis, potential sources of bias,

confounding, conflict of interest, appropriateness of discussion, and validity of conclusions

Advanced Neuropharmacology



Students taking this course examine how drugs work to attack various diseases affecting the nervous

system. They study commonly prescribed medications, learning what they do, what side effects are

possible and which drugs can't be mixed. The class discusses reasons to use drugs to treat a

condition even when the side effects could be bad for the patient. The course also covers the

problem of people developing immunity to a drug or set of drugs.

Advanced Pharmacotherapy



This course aims to:

1. Enable students to recognize the factors that alter patient’s drug response.

2. Build up the ability of applying basic pharmacology knowledge on drugs use in common

medical diseases.

3. Provide students with the essentials of rules and the regulations that govern prescribing

medications.

4. Enable students to identify medication errors, adverse drug reactions, drug interactions and

over dosage.

5. Develop students’ skills in:


• Good communication with patients and families.

• Obtaining accurate drug history.

• Developing a sound drug therapy plan.

• Using information technology.

• Finding evidence-based information.

Drug Safety.



This course tends toDevelop specialized knowledge and skills required to monitor and manage

clinical trials and to conduct drug safety and Pharmacovigilance activities including adverse reaction

reporting and preparing periodic safety update reports. Providing the foundation and practical

knowledge to formulate a sound clinical development plan; ensure clinical trial data is credible and

accurate; and that the rights, integrity and confidentiality of trial subjects are protected

Pharmacoeconomic Applications



In general, the candidates will be able to use the decision analysis to model costs and their outcomes.

E.g. Markov model. Moreover, in view of retrospective databases, the candidate within a team will be

able to evaluate the cost and outcomes associated with Alexandria Faculty of Medicine Hospitals and

Pharmacy services.

An outcome for the pharmacology department is the address and the use of pharmacoeconomic

research in decision making regarding drug policy in major health problems

Advanced toxicokinetics & Drug poisoning



The course aims to help the student to gain advanced knowledge and apply recent laboratory

techniques that helps in understanding the pharmacokinetic aspects of different therapeutic agents and

its implications in the field of drug poisoning and toxicology with exploration of recent guidelines in

their evaluation and management aiming to improve outcome and decrease in both drug related

morbidity and mortality.


Health Outcomes and Health-Related Quality of Life



Course Aims to:

6. Identify the different patient-reported health outcomes and health-related quality of life

measures.

7. Emphasize on the importance of assessing health-related quality of life.

8. Appraise the reliability and validity of assessing health-related quality of life measures.

9. Distinguish common measures of health-related quality of life.

10. Develop students’ skills in assessment of :

• Health-related outcomes.

• Health-related quality of life.

• Quality-adjusted life-years.

• Health state preferences

Clinical Immunology



This course aims to help student to Gain advanced knowledge and clinical skills in diagnosis and

treatment of immunological diseases. Distinguish the role of drug in manipulation of the immunologic

functions to suppress or stimulate cellular and humoural immunity. Recognize the

immunosuppressant drugs in organ transplantation and probable adverse drug reactions. Discuss the

genetic variation affecting drug metabolism and disposition and its reflection on dose modulation and

response to treatment

Herbal use in therapy



By the end of this course the student will Gain advanced knowledge and criticize the highly

practiced herbs by Egyptian populations concerning the international published evidence based one.

Implement national guidelines for optimal use of herb-drug in common disease interventions

7- Programme Admission Requirements: According to the regulations of the credit hour bylaws of the Faculty of Medicine Alexandria University

(annex).

8- Regulations for Progression and Programme Completion: According to the regulations of the credit hour bylaws of the Faculty of Medicine Alexandria University

(annex).


10- Methods of student assessment:

Methods Intended Learning outcomes to be

assessed

1. Essay A1-41, B1-30

2. Case studies A1-41, B1-30, C1-14

3. Assignment A1-41, B1-30, C1-14, D1-16, E1-7.

4. Objective questions A1-41, B1-30, C1-14

5. OSCE/OSPE A1-41, B1-30, C1-14, D1-16, E1-7.

11- Methods of programme evaluation:

Evaluator Tool Sample

1. Questionnaires

2. Alumni

3. Stakeholders (Employers)

4. External Evaluator (s)

5. Others:

Programme Director: Prof. Dr. Samya Mohamed Ali Signature:

Programme coordinator: Prof Dr. Mohamed Gamal El-din Signature:

Date: / /

Course Specifications


Faculty: Medicine

Department: clinical pharmacology

Course Information

Course Code: 051509060 Course Name: Advanced Internal Medicine

Program in which the Course is Given MD in Clinical Pharmacology

Number of Credit Hours Theoretical Clinical/Practical

Course Aims

Students taking this course examine how drugs work to attack various diseases including

neurological, nephrological, ENT, ophthalmic and dermatological diseases. They study commonly

prescribed medications, learning what they do, what side effects are possible and which drugs can't be

mixed. The class discusses reasons to use drugs to treat a condition even when the side effects could

be bad for the patient. The course also covers the problem of people developing immunity to a drug or

set of drugs.

Program ILO (refer to program

matrix) Course ILOs

A. Knowledge and

Understanding

A1. Discuss the pharmacology and

possible effects of a drug and

integrate other disciplines with

clinical pharmacology.

A2. Review the pharmacodynamic

and pharmacokinetic concepts that

will help in understanding basic

drug actions.

A4. List the available targets of

drug action

A5. Describe the characteristic

specification of each target

a1. Discuss the pharmacology and

possible effects of a drug from an

understanding of its mechanism of action

a2. Perform complex medication reviews

and provide advice on judicious

prescribing

a3. Provide in-depth advice on prescribing

in special patient groups, including older

people, children, pregnant and nursing

mothers, and patients with renal or hepatic

disease

a4. Describe clinically important

genotypes that produce atypical patient

responses to medications

a5. Discuss and recognise potential drug

interactions

1 1

A6. Classify each target to

different subcategories and

superfamilies that have been so far

enrolled

A7. Identify linking signaling

cascade of each target and

potential sites where a drug can

possibly intervene starting at cell

surface down to nuclear

modulation and gene expression or

repression

a6. Provide advice on therapeutic drug

monitoring, including dose discussion

calculations

a7. Design and conduct clinical trials

a8. Perform drug utilisation evaluations

a9. Assess adverse drug reactions and

determine causality, and have awareness

of national and international

pharmacovigilance systems

a 10. Diagnose and manage adverse drug

reactions

a 11. Extract and critically evaluate drug

information

a 12. Interpret and develop evidence-

based prescribing guidelines

B. Intellectual skills

B1. Evaluate and provide drug

information

B2. Formulate evidence-based

treatment strategies for important

emergency situations

B3. Correlate the action of drugs

on their targets to their abilities to

achieve a specific therapeutic

outcome

B4. Predict the possibility of

maximizing drug benefits and

minimizing adverse effects based

on the acquired knowledge linked

to the studied signaling cascades

b1. Describe drug safety, including

assessment and management of adverse

drug reactions (adrs),

adverse drug events (ades) and drug error

b.2 Diagnose and manage drug

interactions

b.3 Interpret drug concentrations and give

advice on dose individualisation

b.4 Access, evaluate and provide drug

information

C.Professional and

Practical Skills

C1. Add to the practice of the

specialty and research through

creativity & innovation

C2. Assessment of drug regimens

in different clinical situations in

the hospitalized patients

C3. Criticize specific drugs in

specific situations

c.1 Develop drug policies and actively

contribute to drug-related committee

activities

c.2 Describe, practice and advise on

quality use of medicines (qum)

c.3 Assess and manage issues related to

compliance/adherence/concordance

c.4 Critically review medications and

prescribe rationally

D. General Skills

D1. Hold skills to critically

evaluate evidence presented by

publications

D2. Acquiring new communication

skills in designing and delivering

talks and lectures


D4. Retreive methods for data

search and information analysis

D5. Recognize tools for critique

and peer reviewing

d1. Assess a possible drug interaction in

terms of causality, and classify according

to type

d2. Interpret laboratory data

d3. Write a complete, correct and legal

prescription

d4. Perform complex medication reviews

and provide

advice on judicious prescribing

d5. Promote better prescribing

E. Attitudes

and ethical

behavior

E1. Apply regulations and ethics

that govern physicians in

promotion and detailing of drugs.

E4. Manage confusion of roles in

academic medical centers and

problems with duplicative,

interactive, or conflicting drug

treatment plans

E5. Integrate with other members

of medical team to provide the

patients the appropriate medical

care

E7. Show respect to professors,

colleagues, other members of

medical team and to patients

e1. Apply regulations and ethics that

govern physicians in promotion and

detailing of drugs used in common

internal medicine cases.

e4. Manage confusion of roles in

academic medical centers and problems

with duplicative, interactive, or conflicting

drug treatment plans

e5. Integrate with other members of

medical team to provide the diabetic,

endocrinal and renal patients the

appropriate medical care

e7. Show respect to professors,

colleagues during lectures and oral

presentations, other members of medical

team and to patients during clinical

practice

Course Content (Units/Topics)

Teaching/Learning Methods

Lectures self

learning

Practical/

Clinical

Small

group

discussion

Others

Neuropsychiatry: Epilepsy, Transient

Ischemic Attacks, cerebral infarction

&ischemic Stroke, Parkinsonism,

Peripheral Neuropathies, Meningitis,

Alzheimer disease and other dementias,

Anxiety and depression, Schizophrenia,

obsessive-compulsive disorders &

personality disorders.

✓ ✓ ✓

Nephrology: Acute glomerulonephritis,

Chronic glomerulonephritis, Nephrotic

syndrome, Chronic renal failure

✓ ✓

Dermatology: Topical corticosteroids,

Psoriasis, Vitiligo, Acne valgaris,

Infections and the skin

✓ ✓

Ophthalmology: Cataract, Glaucoma,

Infective conjunctivitis

✓ ✓ ✓

ENT: Chronic rhinosinusitis ✓ ✓

Please check (✓) the appropriate method.

Student Assessment

Methods of Assessment

Essay Objective questions

Case OSCE/OSPE

Assignment Logbook fulfillment

Others

Schedule of Assessment

Mid-term 30 %

End of term 70 %

Distribution of Marks

Written Exam 70 %

Practical/Clinical Exam 30 %

Others %

✓ ✓

✓

✓

List of Textbooks and References

Lecture Notes

✓

Course Text Books

Principles of clinical pharmacology 3rd edition

By: Arthur J. Atkinson

Suggested Extra Reading

Journals and Periodicals, others

• Ann. Rev. Pharmacol

Course Instructor

Name: Signature:

Program Coordinator

Name: Signature:

Program Director (Head of Department)

Name: Signature:



Faculty: Medicine


Course Information

Course Code: 05060901 Course Name: Pharmacology Update I



Course Aims

1.To provide graduate students with the skills of research proposal

2.Appraise the role of cloning in drug discovery

3.Underline the potential applications of nanotechnology in pharmacology

4.Explain in depth the molecular level of drug actiion in the field of cellular calcium regulation,

oxidants/antioxidant balance and stem cell therapy

Intended Learning Outcomes (ILOs)


matrix) Course ILOs

A. Knowledge

and

Understanding


possible effects of a drug and integrate

other disciplines with clinical

pharmacology

A2. Review the pharmacodynamic and

pharmacokinetic concepts that will help

in understanding basic drug actions.

A3. Recognize the essential basics of

pharmacological research

a1.Define different animal models for

pharmacologic studies

a2.Identify the role of transgenic mice in


a3.State the role of cloning in drug

discovery

a4.Outline the molecular basis of drug

action at the level of cellular calcium

regulation, oxidant and antioxidant balance

a5.Identify the role of stem cell in therapy

1 2

B. Intellectual

skills


information



emergency situations.

B3. Correlate the action of drugs on

their targets to their abilities to achieve

a specific therapeutic outcome



minimizing adverse effects based on

the acquired knowledge linked to the

studied signaling cascade

b1.Describe different approaches in stem

cell therapy

b2.Apply the basic knowledge of cellular

calcium regulation as targets of drug action

b3.Apply basic knowledge in

nanotechnology in therapeutics and drug

delivery

b4.Compare animal studies and clinical

trials and how to extrapolate results of

animal studies to human pharmacology

b5.Illustrate approaches of stem cell therapy

C.

Professional

and Practical

Skills

C1. Add to the practice of the specialty

and research through creativity &

innovation

C11. Apply recent advances in

methodology and laboratory

technology in drug research and

clinical investigations

c1. Select appropriate animal models for

different pharmacological experiments

c2.Evaluate the use of transgenic mice in


c3.Recommend new applications of cloning

in drug discovery

D. General

Skills

D1. Hold skills to critically evaluate

evidence presented by publications.


skills in designing and delivering talks

and lectures


D7 Communicate and collaborate

within a team Application level.

d1.Perform practice-based improvement

activities using a systematic methodology

d2.Locate, appraise and assimilate evidence

from scientific studies related to health

problems

d3.Use information technology to manage

information, access on-line medical

information and support self learning.

Attitudes and

ethical

behavior

E1. Apply regulations and ethics that


detailing of drugs.

e1. Apply regulations and ethics that govern

physicians in promotion and detailing of

drugs used in common internal medicine

cases.



with duplicative, interactive, or


E5. Integrate with other members of

medical team to provide the patients

the appropriate medical care


colleagues, other members of medical

team and to patients

e2. Manage confusion of roles in academic

medical centers and problems with

duplicative, interactive, or conflicting drug

treatment plans

e3. Integrate with other members of medical

team to provide the diabetic, endocrinal and

renal patients the appropriate medical care

e4. Show respect to professors, colleagues

during lectures and oral presentations, other

members of medical team and to patients

during clinical practice



Lectures self

learning

Practical/

Clinical

Small group

discussion

Others

1. Differences between animal and

human pharmacology

✓ ✓

2. Animal models of pharmacological

studies

✓ ✓

3. Transgenic mice ✓

4. Role of cloning in crug discovery ✓ ✓

5. Basis and pharmacological

application of nanotechnology

✓ ✓

6. Regulation and dysregulatuion of

celluylar calcium

✓ ✓

7. Oxidative stress and anytooxidants ✓ ✓

8. Stem cell therapy ✓


Student Assessment



Case OSCE/OSPE


Others


Mid-term 30 %

End of term 70 %


Written Exam 70 %


Others %

List of Textbooks and References Lecture Notes

✓

Course Text

Books

• Katzung Basic and Clinical Pharmacology

• Goodman and Gilmen’s the Pharmacological Basis of Therapeutics

• Offemanns, Rosenthal (eds.) Encyclopedia of molecular pharmacology

• Molecular pharmacology: from DNA to drug discovery

• Frontiers in nanobiomedical research: vol. 3: Highlights in Nanomedicine,

Nanotechnology and Pharmacology.

Suggested Extra

Reading

--

Journals and

Periodicals,

others

• British journal of Pharmacology

• Pharmacological review

• Stem cell research

• Cloning and transgenesis

• Drug Discovery Today: Disease Models

Course Instructor

Name: Signature:

Program Coordinator

Name: Signature:


Name: Signature:

✓ ✓

✓

✓



Faculty: Medicine


Course Information

Course Code: 05060901 Course Name: Pharmacology Update II



Course Aims This course is intended for the recognition of the different possible targets of drug action. It helps to specify the level along any of the signaling cascade where a drug can possibly intervene to positively or negatively achieve a beneficial therapeutic outcome. It further encourages selection between similar group of drugs in light of their specificity and selectivity to a specified target. It will also permit extrapolation of acquired data to new areas that can be targeted and open genuine avenues for approaching such areas.



matrix) Course ILOs

A. Knowledge

and

Understanding




A6. Classify each target to different

subcategories and superfamilies that have

been so far enrolled

A7. Identify linking signaling cascade of

each target and potential sites where a

drug can possibly intervene starting at cell

surface down to nuclear modulation and


A8. Describe the final outcome of

modulating the different selected targets

A1.Classify drug transporters

A2.Enumerate different types of channels

A3.State different cell surface receptors

A4.Explain different modalities of

transcription regulation

A5.Locate the different phases of cell cycle

A6. Compare active and facilitated

transporters

A7. Classify active trasporters

A8. Describe different checkpoints

A9. Identify the characteristic specification of

each target

3

in terms of survival and death

A10. Identify linking signaling cascade of each

target and potential sites where a drug can

possibly intervene starting at cell surface down

to nuclear modulation and gene expression or

repression

B. Intellectual

skills

B3. Correlate the action of drugs on their

targets to their abilities to achieve a

specific therapeutic outcome

B4. Predict the possibility of maximizing

drug benefits and minimizing adverse

effects based on the acquired knowledge

linked to the studied signaling cascades

B5. Analyze areas of signaling cross talk

where a single drug can act instead of

several drugs

B6. Allocate potential signaling molecules

that could be a target for new drug

development

B7. Suggest a new targets where drugs can

be used in regenerative therapy versus

those that can be eliminate undesirable

cell lines

B1. Demonestrate how targeting the canonical

versus non-canonical pathway of receptor

signaling vary in drug action

B2.Utelize the varied signaling pathway to

explain the concept of biased agonists and

biased modulators

B3.Detect the importance of cell surface

receptors cross talk in the action of growth

factors and cytokines

B4. Identify potential signaling molecules that

could be a target for new drug development

B5. Review a new targets where drugs can be

used in regenerative therapy versus those that

can be eliminate undesirable cell lines

C.

Professional

and Practical

Skills

none

D. General

Skills

D2. Acquiring new communication skills in

designing and delivering talks and lectures

D1.Develop communication skills in

presenting assignments

D2.Appraise good behavioral conduct and


D4. Retrieve methods for data search and

information analysis

D5. Recognize tools for critique and peer

reviewing

reject mal performance

D3.Construct checklist to assess scientific

and behavior conduct of colleagues.

Attitudes and ethical behavior




E1. Show respect to professors, colleagues

during lectures and oral presentations



Lectures self

learning

Practical/

Clinical

Small

group

discussion

Others

1. Targeting drugs to different biological molecules

✓ ✓

2. Drugs acting on transporter proteins or interacting with biological barriers

✓

3. Drugs acting on ion channels

4. Drugs acting through cell surface receptors

✓ ✓

5. Drugs acting as or activating transcription factors

✓ ✓

6. Drugs acting on nuclear receptors ✓ ✓ ✓

7. Epigenetic therapy and gene therapy ✓ ✓

8. Drugs promoting cell survival and drugs inducing apoptosis

✓ ✓


Student Assessment



Case OSCE/OSPE


Others


Mid-term 30 %

End of term 70 %


Written Exam 70 %

Practical/Clinical Exam

Others (ASSIGNMENT) 30%


Lecture Notes

✓

Course Text Books

1. Molecular Pharmacology; from DNA to Drug Discovery By; Dickenson, Freeman, Mills, Sivasubramaniam, Thode

2. Molecular Cell Biology By Lodish, Berk, Scott, Krieger, Darnell, Kaiser, Zipursky, Matsudaira

• .


Albert's Molecular biology of the cell



• Pharmacological review

• Stem cell research

• Cloning and transgenesis

• Drug Discovery Today: Disease Models

Course Instructor

Name: Signature:

✓ ✓

✓

Program Coordinator

Name: Signature:


Name: Signature:



Faculty: Medicine


Course Information

Course Code: 05060903 Course Name: Advanced clinical

pharmacokinetics and pharmacodynamics


Number of Credit Hours 2 Theoretical Clinical/Practical

Course Aims

This course is intended to give advanced knowledge and application in clinical pharmacology.

Understanding the importance of drug monitoring. Discuss the role of dose adjustment for certain drugs

to improve patient treatment



matrix) Course ILOs

A. Knowledge

and

Understanding




pharmacology.



in understanding basic drug actions.

A9. Recognize the importance of dose

adjustment of some antimicrobial drugs

A10. Evaluate the importance of drug

monitoring of certain drugs



a1.calcultae volume of distribution, t-half,

elimination rate constant, time to steady

state of aminoglycosides, vancomycin, anti-

epileptic drugs, immunosuppressant drugs

and drugs with narrow therapeutic index

a2.predict the dose of these drugs in

different diseases that affect drug kinetics

1 1

A12. Discuss the pharmacokinetics of

drugs with narrow therapeutic index

B. Intellectual

skills

B8. Design the therapeutic regimen of

drugs depending on the desired steady

state plasma level

b1. specify the needed dose and the dose

interval in renal or hepatic impairment

C.

Professional

and Practical

Skills

C2. Assessment of drug regimens in

different clinical situations in the

hospitalized patients

c1. recommend the dose regimen to

improve the use of drugs in critical disease

situations

D. General

Skills



and lectures


D4. Retrieve methods for data search

and information analysis

D5. Recognize tools for critique and

peer reviewing

D14. Participate in experimental

studies

d1.develop communication skills in

presenting assignments

d2.appraise good behavioral conduct and

reject mal performance

d3.construct checklist to assess scientific

and behavior conduct of colleagues.

d4. participate in experimental studies to

assess drug kinetics and dynamics

Attitudes and

ethical

behavior




E6. Apply regulations and ethics during

laboratory work on experimental

animals




e1. integrate with other members of medical

team to provide the patients the appropriate

medical care, applying the studied criteria

regarding pharmacokinetic and dynamic

properties of drugs

e2. apply regulations and ethics during

laboratory work

e3. show respect to professors, colleagues

during lectures and oral presentations



Lectures self

learning

Practical/

Clinical

Small

group

discussion

Others

Application of pharmacokinetic

principles in clinical use of:

1. Antibiotics

✓ ✓ ✓

2. Cardiovascular agents ✓ ✓ ✓

3. Anticonvulsants ✓ ✓

4. Immunosuppressants ✓ ✓ ✓

5. Other drugs ✓ ✓ ✓


Student Assessment



Case OSCE/OSPE


Others


Mid-term 30 %

End of term 70 %


Written Exam 70 %


Others (ASSIGNMENT) 30%

✓ ✓

✓


Lecture Notes

✓

Course Text Books

Principles of clinical pharmacology

Applied therapeutics the clinical use of

drugs

• .


Clinical pharmacology


• J clin ther

• J clin Pharm

• Pharmacotherapy

Course Instructor

Name: Signature:

Program Coordinator

Name: Signature:


Name: Signature:



Faculty: Medicine


Course Information

Course Code: 05060904 Course Name: Advanced Drug Discovery and development



Course Aims

Acquire advanced knowledge and apply recent techniques that help in exploring Drug discovery and

Development, in light of new and Novel criteria Targeted Drug Discovery and Development aiming

to reach the best Innovative Translational Strategies to Discover & Develop Drugs.



matrix) Course ILOs

A. Knowledge

and

Understanding

A13. Distinguish Phase I Clinical

Studies

a.1 Describe Essential Research and Study

Skills

a.2 Identify Modern Pre- to Post-Clinical

Research

a.3 Discuss Registration of Drugs and

Pharmaceutical Products

a.4 Discuss Advanced Drug Design.

a.14 Describe Pharmacokinetic and

Pharmacodynamic Considerations in

the Development of Biotechnology


a.5 Identify Biochemical and Molecular

Methods in Toxicology

a.6 Discuss Cell Culture Techniques

a.7 Identify Molecular Techniques

a.8 Distinguish Immunochemical Techniques

A15 Distinguish Design of Clinical

Development Programs

a.9 Discuss Cell Signalling Pathways for

Drug Discovery

a.10 Point Discovery Approaches for

Neglected Tropical Diseases

a.11 Summarize Drug Repurposing,

Repositioning and Orphan Drugs

a.12 Point GPCR based Drug Design

a.13 Identify Innovative Translational

Strategies to Discover & Develop Drugs

1 2

a.14 Summarize Novel Screening

Methodologies for Drug Discovery

a.15 Point Novel Therapeutic Targets using

Chemical Biology

a.16 Recognize Pre-Clinical Drug

Development

a.17 Distinguish Success in Drug Discovery

a.18 Identify Targetting Protein-Protein

Interactions

a.19 Describe Targeted Drug Discovery and

Development.

a.16 Distinguish Role of the

Administration (e.g. FDA) in Guiding

Drug Development

a.20 Discuss Planning Clinical Trial program

(use of preclinical and Phase I data)

a.21 Point Study types and designs

a.22 Discuss Study conduct

a.23 Summarize Quality control and quality

assurance

a.24 Summarize Adverse Events (definitions,

collection, reporting, assessment, coding)

a.25 Identify Interpretation of study design,

analysis and results.

a.17Distinguish clinical applications

of Drug Discovery and development

a.26 Interpret Clinical application in drug

research center

a.27 Outline Project in drug development

a.28 Distinguish Clinical training in

pharmaceutical companies.

B. Intellectual

skills

B9. Design Phase I Clinical Studies

b1. Sort Essential Research and Study Skills

b2. Transform Modern Pre- to Post-Clinical

Research

b3. Distinguish Registration of Drugs and


b4. Contrast Advanced Drug Design.

B10. Apply Pharmacokinetic and

Pharmacodynamic Considerations in

the Development of Biotechnology


b5. Compose Biochemical and Molecular


b6. Distinguish Cell Culture Techniques

b7. Distinguish Molecular Techniques

b8. Distinguish Immunochemical

Techniques.

B11. Construct Design

of Clinical Development

Programs

b9. Appraise Cell Signalling Pathways for

Drug Discovery

b10. Contrast Discovery Approaches for


b11. Build Drug Repurposing, Repositioning

and Orphan Drugs

b12. Appraise GPCR based Drug Design

b13. Compose Innovative Translational

Strategies to Discover & Develop Drugs

b14. Analyze Novel Screening

Methodologies for Drug Discovery

b15. Analyze Novel Therapeutic Targets

using Chemical Biology

b16. Distinguish Pre-Clinical Drug

Development

b17. Contrast Success in Drug Discovery

b18. Distinguish Targetting Protein-Protein

Interactions

b19. Relate Targeted Drug Discovery and

Development.

B12. Construct Role of

the Administration (e.g.

FDA) in Guiding Drug

Development

b20. Operate Planning Clinical Trial program

(use of preclinical and Phase I data)

b21. Contrast Study types and designs

b22. Apply Documentation (protocols,

reports, source documents, case report

forms, study master file, investigator’s

brochure).

b23. compose Study conduct

b24. Analyze Quality control and quality

assurance

b25. Appraise Adverse Events (definitions,

collection, reporting, assessment,

coding)

b26. Interpretation of study design, analysis

and results.

b.13 Criticize clinical applications of

Drug Discovery and development

b27. Appraise Clinical application in drug

research center

b28. Criticize Project in drug development

b29. Compose Clinical training in


C.Professional

and Practical

Skills

C3. Criticize specific drugs in

specific situations

C1. Apply update in Personalized Medicine, ,

C2. Appraise update pharmacologic knowledge

to select the best drug for a particular Elderly

and Pediatric Populations

C3. Solve problems of Orphan Drugs,

Comparative Effectiveness, Combination

Treatments, Transparency...etc.

D. General

Skills

d1. Hold skills of class discussion

and critical evaluation of

evidence presented by

publications or industry.

d1. Demonstrate competent presentation and

knowledge in class and respect questions

and inquires from colleagues and

professors.

d2. Prove efficient skills in searching databases

and evidence-based guidelines.

d3. Display good time-management during talk,

case presentation and discussion.

Attitudes and

ethical

behavior



team and to patients.

e1. Show respect to professors, colleagues,

during lectures and discussion



Lectures self

learning

Practical/

Clinical

Small

group

discussion

Others

1. Essential Research and Study

Skills

✓ ✓

2. Modern Pre- to Post-Clinical

Research

✓ ✓

3. Registration of Drugs and


✓ ✓

4. Advanced Drug Design ✓ ✓

5. Biochemical and Molecular


✓ ✓

▪ Cell Culture Techniques ✓ ✓

▪ Molecular Techniques ✓

▪ Immunochemical

Techniques

✓ ✓

6. Cell Signalling Pathways for

Drug Discovery

✓ ✓

7. Discovery Approaches for


✓ ✓

8. Drug Repurposing,

Repositioning and Orphan

Drugs

✓

9. GPCR based Drug Design ✓

10. Innovative Translational

Strategies to Discover &

Develop Drugs

✓

11. Novel Screening Methodologies

for Drug Discovery

✓

12. Novel Therapeutic Targets using

Chemical Biology

✓

13. Pre-Clinical Drug Development ✓

14. Success in Drug Discovery ✓

15. Targetting Protein-Protein

Interaction.

✓

16. Targeted Drug Discovery and

Development

✓ ✓

17. Planning Clinical Trial program

(use of preclinical and Phase I

data)

✓ ✓

18. Study types and designs ✓ ✓

19. Documentation (protocols,

reports, source documents, case

report forms, study master file,

investigator’s brochure).

✓ ✓

20. Study conduct ✓ ✓

21. Quality control and quality

assurance

✓ ✓

22. Adverse Events (definitions,

collection, reporting,

assessment, coding)

✓ ✓

23. Interpretation of study design,

analysis and results.

✓ ✓

Practical:

1. Clinical application in drug

research center

✓

2. Project in drug development ✓

3. Clinical training in


✓


Student Assessment



Case OSCE/OSPE


Others


Mid-term 40 %

End of term 60 %


Written Exam 60 %


Others (attendance/Assignment) %


Lecture Notes

Manuscripts of Assignment Topics prepared by

candidates and revised by supervising professors.

Course Text Books

Drug Discovery and Development

UNDERSTANDING THE R&D PROCESS (by

innovation.org)

Biopharmaceutical Research &

Development: The Process Behind New

Medicines (www.phrma.org)


1) Katzung basic and clinical Pharmacology

2) Lippincot' s Pharmacology review

3) Goodman and Gillman Basic Pharmacology.


Review articles on pubmed and Medscape on Drug

discovery and Development

for more information: www.phrma.org

Course Instructor

Name: Signature:

Program Coordinator

Name: Signature:


Name: Signature:

✓ ✓

✓

✓ ✓



Faculty: Medicine


Course Information

Course Code: 05060905 Course Name: Biostatistics and data

management in clinical trials



Course Aims

The candidates will be able to

Design a clinical trial, collect data, analyze and interpret results.

Use evidence based medicine

Critically analyses papers regarding rationale, cogency, experimental design, analytical methodology,

method of analysis, potential sources of bias, confounding, conflict of interest, appropriateness of

discussion, and validity of conclusions.


Program ILO (refer to program matrix) Course ILOs

A. Knowledge

and

Understanding

A18. Design a clinical trial, collect

data, analyze and interpret results.

al- Identify the rules regulating clinical

trials

a2- Define hypothesis testing, The null

hypothesis, Type I and II errors,

significance and power

a3- Discuss Risk factors, confounding

variables

a4- Enumerate types of data

a5-Explain Variations in biometry in

population, in disease

a6- Discuss Types of analysis

a7- Outline study design

1

a8-.Define evidence based medicine

a9- Assess violations, withdrawals, errors,

bias

a10- Discuss Sources of bias

a 11- Explain Statistical principles and

issues in report writing: data manipulation,

transposition, merging

B. Intellectual

skills

B14. Assess the presence or absence

of significant difference

between different groups of the

clinical trial, using the

appropriate statistical test

bl- Apply the studied statistical principles to

test the null hypothesis

b2- Compare Paired and non-paired tests,

parametric and non-parametric tests

B15 - Critically analyses papers

b3- Critique six studies regarding rationale,

cogency, experimental design, analytical

methodology, method of analysis, potential

sources of bias, confounding, conflict of

interest, appropriateness of discussion,

validity of conclusions

b4- Design/ practice a clinical trial to

compare new drugs with standard therapy

C.

Professional

and Practical

Skills

C4. Use computer programs to assess

the level of significance between

different groups of a study

c1. Use computer programs to assess the

level of significance between different

groups of a study

c2. Interpret graphs to get statistical

informations

c3. Acquire personal/professional skills

(e.g. functioning within an organization)

D. General

Skills

D1 Hold skills to critically


publications

d1. Communicate and share ideas with

professors to Use the computer statistical

programs

d2. Communicate and collaborate within a

team Application level

d3. Participate in Conceptualization level

Attitudes and

ethical

behavior







Teaching/Leang Methods

Lectures self

learning

Practical/

Clinical

Small

group

discussion

Others

1. Trial design, hypothesis testing,

power

• Pre-trial decisions and specification

• Risk factors, confounding variables

• The null hypothesis, Type I and II

errors, significance, power

✓ ✓

2. Measurement and types of data

• Standardization

• Variations in biometry in

population, in disease

✓ ✓

3. Data collection and management

• Creation, maintenance and security

of databases, software validation and

archiving

• Data management from clinical

trials: corrections verifications and

extraction

• Within-trial decisions, data

management, extraction and

manipulation

✓ ✓

4. Types of analysis

• Analysis of efficacy end-points and

of safety

• Paired and non-paired tests,

parametric and non-parametric tests,

confidence limits

• Handling of rating and visual

analogue scales, patient diaries and

laboratory values

✓ ✓

5. 5. Interpretation of study design,

analysis and results

• Assessment of violations,

withdrawals, errors, bias

• Statistical principles and issues in

report writing: data manipulation,

transposition, merging

• Clinical interpretation of trial

• Final report writing and formatting for

registration dossier and publications

✓ ✓

6. What is evidence based medicine

and Causation

Searching the medical literature

Study design and strength of evidence

✓ ✓

7. Instruments and measurements

strength and validity

Sources of bias

Hypothesis testing

Types of error and number needed to

treat

✓ ✓

8. Method of analysis, potential sources

of bias, confounding, conflict of

interest, appropriateness of discussion,

validity of conclusions.

✓ ✓


Student Assessment



Case OSCE/OSPE


Others


Mid-term 30 %

End of term 70 %


Written Exam 100 %


Others %

✓

✓

✓ ✓


Lecture Notes

✓

Course Text Books

• Karen L.Rasacati (2014), Essentials of

Pharmacoeconomics, 2nd ed., Wolters

Kluwer, Lippincott, William & Wilkins

Austin, Texas.

• Copeland, R. A., and Anderson, P. S.

(2002), in Textbook of Drug Design and

Discovery, 3rd ed., P. Krogsgaard-

Larsen, T. Liljefors, and U. Madsen, eds.,

Taylor and Francis, New York,


International Society for Pharmacoeconomics

and Outcomes Research membership


Publications of ISPOR= International Society

for Pharmacoeconomics and Outcome

research)

Egyptian Guidelines and reports for Reporting

Pharmacoeconomic Evaluations

Course Instructor

Name: Prof. Inas Darwish Signature:

Program Coordinator

Name: Signature:


Name: Signature:



Faculty: Medicine


Course Information

Course Code: 05060906 Course Name: Advanced Neuropharmacology



Course Aims

Students taking this course examine how drugs work to attack various diseases affecting the nervous

system. They study commonly prescribed medications, learning what they do, what side effects are

possible and which drugs can't be mixed. The class discusses reasons to use drugs to treat a condition

even when the side effects could be bad for the patient. The course also covers the problem of people

developing immunity to a drug or set of drugs.


matrix) Course ILOs

A. Knowledge

and

Understanding




pharmacology.



in understanding basic drug actions

A9. Recognize the importance of dose

adjustment of some antimicrobial drugs

A10. Evaluate the importance of drug

monitoring of certain drugs



A12. Discuss the pharmacokinetics of

drugs with narrow therapeutic index

a1. Discuss the pharmacology and possible

effects of a drug from an understanding of

its mechanism of action

a2. Perform complex medication reviews

and provide advice on judicious prescribing

a3. Provide in-depth advice on prescribing

in special patient groups, including older

people, children, pregnant and

nursing mothers, and patients with renal or

hepatic disease

a4. Describe clinically important genotypes

that produce atypical patient responses to

medications

a5. Discuss and recognise potential drug

interactions

a6. Provide advice on therapeutic drug

monitoring, including dose discussion

calculations

1 1

a7. Design and conduct clinical trials

a8. Perform drug utilisation evaluations

a9. Assess adverse drug reactions and

determine causality, and have awareness of

national and international

pharmacovigilance systems

a 10. Diagnose and manage adverse drug

reactions

a 11. extract and critically evaluate drug

information

a 12. interpret and develop evidence-based

prescribing guidelines

B. Intellectual

skills


information

B3. Correlate the action of drugs on

their targets to their abilities to achieve

a specific therapeutic outcome



minimizing adverse effects based on

the acquired knowledge linked to the

studied signaling cascades

b1. Describe drug safety, including

assessment and management of adverse

drug reactions (adrs),

adverse drug events (ades) and drug error

b.2 Diagnose and manage drug interactions

b.3 Interpret drug concentrations and give

advice on dose individualisation

b.4 Access, evaluate and provide drug

information

C.Professional

and Practical

Skills



innovation




C3. Criticize specific drugs in specific

situations

c.1 Develop drug policies and actively

contribute to drug-related committee

activities

c.2 Describe, practice and advise on quality

use of medicines (QUM)

c.3 Assess and manage issues related to

compliance/adherence/concordance

c.4 Critically review medications and

prescribe rationally

D. General

Skills


evidence presented by publications



and lectures


d1. Assess a possible drug interaction in

terms of

causality, and classify according to type

d2. Interpret laboratory data

d3. Write a complete, correct and legal

prescription

d4. Perform complex medication reviews

and provide

advice on judicious prescribing

d5. Promote better prescribing

Attitudes and

ethical

behavior



detailing of drugs.

E2. Obtain consent that is truly

informed

E3. Manage special challenges of

performing clinical research in

vulnerable populations



with duplicative, interactive, or








e1 Apply regulations and ethics that govern

physicians in promotion and detailing of

neurological ddrugs.

e2. Obtain consent that is truly informed

before patient participation in any trials

e3. Manage special challenges of

performing clinical research in vulnerable

populations

e4. Manage confusion of roles in academic

medical centers and problems with

duplicative, interactive, or conflicting

neurological drug treatment plans

e5. Integrate with other members of medical

team to provide the patients the appropriate

medical care for common neurological

diseases


other members of medical team and to

patients.in teaching and medical practice



Lectures self

learning

Practical/

Clinical

Small

group

discussion

Others

Basic Principles of

Neuropharmacology, Cellular Basis of

Communication, Synaptic

Transmission, Pain, Neuroinflammation

✓ ✓ ✓

Sleep and Arousal, Higher Cognitive

Function and Behavioral Control, Mood

and Emotion, Reinforcement and

Addictive Disorders, Schizophrenia and

Bipolar Disorder, Neurodegeneration,

Seizure Disorders, Stroke and Migraine.

✓ ✓

http://neurology.mhmedical.com/content.aspx?bookid=1204&sectionid=72648697


















Atypical Neurotransmitters, Autonomic

Nervous System, Neural and

Neuroendocrine Control of the Internal

Milieu

✓ ✓ ✓

Signal Transduction in the

Brain, Excitatory and Inhibitory

Amino Acids, Widely Projecting

Systems: Monoamines,

Acetylcholine, and Orexin,

Neuropeptides

✓ ✓ ✓

Please check (✓) the appropriate method

Student Assessment



Case OSCE/OSPE


Others


Mid-term 30 %

End of term 70 %


Written Exam 70 %


Others %

✓ ✓

✓

✓
















Lecture Notes

✓

Course Text Books

Molecular Neuropharmacology: A Foundation

for Clinical Neuroscience, 3e

Eric J. Nestler, MD, PhD, Steven E. Hyman,

MD, David M. Holtzman, MD, Robert C.

Malenka, MD, PhD



• Ann. Rev. Pharmacol

Course Instructor

Name: Signature:

Program Coordinator

Name: Signature:


Name: Signature:



Faculty: Medicine


Course Information

Course Code: 05060907 Course Name: Pharmacotherapy (Rational use of drugs)


Number of Credit Hours: 4 Theoretical Clinical/Practical

Course Aims to:

1. Enable students to recognize the factors that alter patient’s drug response.

2. Build up the ability of applying basic pharmacology knowledge on drugs use in common

medical diseases.

3. Provide students with the essentials of rules and the regulations that govern prescribing

medications.

4. Enable students to identify medication errors, adverse drug reactions, drug interactions and over

dosage.

5. Develop students’ skills in:

• Good communication with patients and families.

• Obtaining accurate drug history.

• Developing a sound drug therapy plan.

• Using information technology.

• Finding evidence-based information.


Program ILO Course ILOs

A. Knowledge

and

Understanding


possible effects of a drug and

integrate other disciplines with

clinical pharmacology.

A2. Review the pharmacodynamic

and pharmacokinetic concepts that

A1.Identify principles of rational drug use.

A2.Discuss clinical use of antimicrobial drugs.

A3.Outline management of rheumatoid Arthritis.

A4. Explain the clinical use of antiepileptic drugs.

A5. State lines of pain management.

A6. Describe the mechanism of action and drug

interactions related to the management of

common medical diseases.

2 2

will help in understanding basic drug

actions.

A19. Review recent guidelines in

management of common diseases.

B. Intellectual

skills


information



emergency situations



clinical situations.

B1. Apply drug therapy individualization in

patients with:

• Renal insufficiency.

• Hepatic disease.

• Metabolic genetic alterations.

B2.Apply therapeutic approaches for management

of: heart failure, ischemic heart disease, acute

coronary syndromes, atrial fibrillation, essential

hypertension, hypertensive emergency and

hyperlipidemia.

B3.Illustrate emergency management of different

types of shock, cardiopulmonary arrest, and

diabetic ketoacidosis.

B4. Formulate therapeutic strategies for common

acute and chronic gastrointestinal, neurologic,

immunologic, hematologic, rheumatologic,

infectious, and endocrinal disorders.

B5. Employ the special precautions needed in

pediatric and geriatric patients and pregnancy.

C.

Professional

and Practical

Skills

C1 Add to the practice of the






C3. Criticize specific drugs in specific

C1.Criticize different therapeutic approaches for

common medical problems.

C2.Organize a plan for therapeutic management

of patients with comorbidities.

C3.Apply the pharmacological knowledge in

finding common medical errors.

situations

C5. Implement drug safety on

rational drug use


C4.Design systematic approaches for emergency

management.

C5.Use trials to compare the appropriateness of

different therapeutic approaches in specific

populations.

D. General

Skills

D1 Hold skills to critically


publications.


skills in designing and delivering

talks and lectures


D1.Perform practice-based improvement activities

using a systematic methodology.

D2.Appraise evidence from scientific studies.

D3.Participate in one audit related to

pharmacology.




detailing of drugs.

E2. Obtain consent that is truly

informed

E3. Manage special challenges of

performing clinical research in

vulnerable populations


academic medical centers and

problems with duplicative,

interactive, or conflicting drug

treatment plans


medical team to provide the

patients the appropriate medical

care



.E1 Apply regulations and ethics that govern

physicians in promotion and detailing of variable

prescribed drugs.

E2. Obtain consent that is truly informed before

patient participation in any trials

E3. Manage special challenges of performing clinical

research in vulnerable populations

E4. Manage confusion of roles in academic medical

centers and problems with duplicative, interactive, or


E5. Integrate with other members of medical team to

provide the patients the appropriate medical care for

common diseases

E7. Show respect to professors, colleagues, other

members of medical team and to patients.in teaching

and medical practice

medical team and to patients.



Lectures self

learning

Practical/

Clinical

Small

group

discussion

Others

A. Recent guidelines in

management of common

diseases.

✓ ✓

B. General concepts:

1. Principles of rational drug use ✓

2. Clinical Use Of Antimicrobial

Drugs

✓

3. Clinical Use of HCV & HIV

Drugs

✓

4. Management of Rheumatoid

Arthritis

✓

5. Drug Therapy Individualization

in Patients with Hepatic Disease

or Genetic Alterations in Drug

Metabolizing Activity

✓ ✓

6. Clinical Use of Antiepileptic

Drugs

✓

7. Drug Therapy Individualization

for Patients with Renal

Insufficiency

✓ ✓

8. Pain Management

✓

C. Clinical sessions: Problem

based learning on

C.V.S. Disorders - I

Essential Hypertension

Hypertensive emergency

Hypertension in pregnancy

Heart Failure

✓ ✓ ✓

C.V.S. Disorders - II

Ischemic Heart Disease

✓ ✓

✓

Acute Coronary Syndromes

Atrial Fibrillation

Hyperlipidemia

Respiratory Disorders:

Bronchial Asthma

Community Acquired Pneumonia

Nosocomial Pneumonia

Tuberculosis

✓ ✓ ✓

GIT Disorders:

Chronic Inflammatory Bowel Disease

Peptic Ulcer Disease

Portal Hypertension and Cirrhosis

Viral Hepatitis

Traveler’s Diarrhea

✓

Neurologic Disorders:

Ischemic Stroke

Generalized Tonic-Clonic Seizures.

Parkinson’s Disease

Migraine

✓ ✓ ✓

Endocrinology, Metabolism, and

Diabetes Disorders- I:

Diabetes Mellitus (NIDDM)

Diabetes Mellitus (IDDM)

Hyperthyroidism

Hypothyroidism

✓ ✓ ✓

Immunologic And Rheumatologic

Disorders:

Rheumatoid Arthritis

Osteoarthritis

Gout and Hyperuricemia

Solid-Organ Transplantation

✓ ✓ ✓

Hematologic Disorders:

Iron Deficiency Anemia

Megaloplastic Anemia

Acute Leukemia

HIV infection

✓ ✓ ✓

Infectious Disease-I:

Bacterial Meningitis

Typhoid fever

Osteomyelitis

Urinary Tract Infections

✓ ✓ ✓

Infectious Disease-II:

Cellulitis

Infective Endocarditis

Intraabdominal Infections

Gonorrhea

✓ ✓ ✓

Pediatric Disorders:

Pediatric Gastroenteritis

Rheumatic fever

Meningitis in childhood

Acute childhood leukemia

✓ ✓ ✓

Geriatric Disorders:

Dementia

Urinary Incontinence

Osteoporosis

✓ ✓ ✓

Emergency:

Cardiopulmonary Arrest

Anaphylactic shock

Sepsis and Septic Shock

Diabetic ketoacidosis

✓ ✓ ✓

Student Assessment



Case OSCE/OSPE


Others


Mid-term 30 %

End of term 70 %


Written Exam 70 %


Others:


Lecture Notes

Course Text Books

• Katzung Basic and Clinical

Pharmacology

• Martindale: The Extrapharmacopoeia

• JM Ritter, LD Lewis, TG Mant & A

✓ ✓

✓

✓

Ferro (Eds.), A Textbook of Clinical

Pharmacology and Therapeutics.

• Harrison’s Principles of Internal

Medicine




• The Journal of Clinical Pharmacology

Course Instructor:

Name: Signature:

Program Coordinator:

Name: Signature:

Program Director (Head of Department):

Name: Signature:



Faculty: Medicine


Course Information

Course Code: 05060908 Course Name: Drug Safety



Course Aims

Develop specialized knowledge and skills required to monitor and manage clinical trials and to conduct

drug safety and Pharmacovigilance activities including adverse reaction reporting and preparing

periodic safety update reports. Providing the foundation and practical knowledge to formulate a sound

clinical development plan; ensure clinical trial data is credible and accurate; and that the rights,

integrity and confidentiality of trial subjects are protected



matrix) Course ILOs

1

A. Knowledge

and

Understanding

A20. Understand concept of drug

safety

A21. Recognize adverse drug reactions

A22. Recognize glossary of terms used

in Pharmacovigilance

A1.Explain the role of drug safety in the

successful development and usage of a

medicine to the benefit of patients.

A2. Identify frequent pitfalls related to drug

safety considerations

A3. Discuss how changes in safety

assessment could become part of a new

drug development paradigm

A4. Outline the classification of adverse

events / adverse drug reactions.

A5. Describe the safety reporting

requirements (according to the type of

adverse event / reaction) pre- and post-

approval.

A6. Review causality, severity, probability

of adverse drug reactions

B. Intellectual

skills

B17. Choose tools, techniques and

methodologies in dug safety evaluation

B18. Assess impact of adverse drug

reactions on adherence of patients to

drugs

B19. Evaluate principal methodological

challenges in the reporting, analysis

and interpretation of safety data in

B1.Choose tools, techniques and

methodologies in dug safety evaluation

B2. Evaluate the assessment of causality.

B3.Distinguish the etiology, mechanisms

and pathology of major classes of adverse

drug reactions and interactions.

B4. Appreciate what safety-related

questions need to be answered in early and

late drug development

clinical trials B5. Evaluate principal methodological

challenges in the reporting, analysis and

interpretation of safety data in clinical trials

C.

Professional

and Practical

Skills

C5. Implement drug safety on rational

drug use



innovation


C1. Critically appraise the principles of

risk-benefit analysis and management using

qualitative and quantitative approaches.

C2. Add to the practice of the specialty and

research through creativity & innovation

C3. Appreciate the role of various centers in

practicing drug safety monitoring

D. General

Skills



D1. Critically review and interpret the

literature relating to drug safety and usage

D2.Hold skills to critically evaluate


concerning drug safety.





E1. Show respect to professors, colleagues

during lectures and oral presentations, other

members of medical team and to patients

during clinical practice



Lectures self

learning

Practical/

Clinical

Small

group

discussion

Others

1. Pharmacovigilance Regulations

and Good Pharmacovigilance

✓

Practices (GVP)

2. Organization of a Typical Drug

Safety Department

✓

3. Adverse Drug Reaction types

and Reporting

✓

4. Post Marketing Compliance for

Safety Monitoring

✓

5. Clinical Study and Safety

Reporting Activities

✓

6. GVP Inspections and Audits

7. Clinical Research, Drug Safety,

Pharmacovigilance Project

✓

8. Drug interactions ✓

9. Immune mechanisms in drug

hypersensitivity and Cutaneous

manifestations of adverse drug

reactions

✓

10. Organ specific adverse drug

reactions

✓

11. Pharmacogenetics and

metabolic basis for adverse

drug reactions

✓

12. FDA Publications , Updates and

Medwatch

13. Safe use of drugs in certain

disease conditions, pregnancy,

lactation, elderly and children


Student Assessment



Case OSCE/OSPE


Others


Mid-term 30 %

End of term 70 %


Written Exam 70 %


Others 30 %


Lecture Notes

✓

Course Text Books

• 1. Cobert's Manual of Drug Safety and

Pharmacovigilance 2nd Edition


• Oxford Handbook of Practical Drug

Therapy (2 ed.).Duncan Richards, Jeffrey

✓ ✓

✓

Aronson, D. John Reynolds, and Jamie

Coleman


• Cobert's Manual Of Drug Safety And

Pharmacovigilance: Medicine & Health

Science Books @ Amazon.com.

Course Instructor

Name: Azza Baraka Signature:

Program Coordinator

Name: Signature:


Name: Samia Mohammed Ali Signature:



Faculty: Medicine


Course Information

Course Code: 05060909 Course Name: Pharmacoeconomic

Applications



Course Aims

In general, the candidates will be able to use the decision analysis to model costs and their outcomes.

E.g. Markov model. Moreover, in view of retrospective databases, the candidate within a team will be

able to evaluate the cost and outcomes associated with Alexandria Faculty of Medicine Hospitals and

Pharmacy services.

An outcome for the pharmacology department is the address and the use of pharmacoeconomic

research in decision making regarding drug policy in major health problems



matrix) Course ILOs

A. Knowledge

and

Understanding

A23 Recognize recent updates in

measuring costs and sensitivity

analysis

al- Identify the decision analysis

a2- Point the purpose of decision analysis

a3- Label a decision tree

a4- Interpret threshold analysis graphs

a5-Explain when Markov modeling may be

useful

a6- Interpret a pictorial; presentation of

Markov model

a7- outline types of retrospective data base

a8-Predict the importance of measuring

costs and patient outcomes associated with

medication therapy management for high

1 1

risk Medicare patient

a9-Discuss the pharmacoeconomic results

from different countries

a10- paraphrase updated references and

websites on worldwide pharmacoeconomic

guidelines

B. Intellectual

skills

B20. Calculation of average costs

bl- Calculate the average costs and outcome

from a decision tree

b2- Compare and contrast the use of data

from randomized clinical trials (RCT)

versus observation from pharmacoeconomic

study

B21- Share in six studies

b3- Critique six studies that use

retrospective database

b4- Design/ practice a pharmacoeconomic

study that evaluate therapeutic service in

Alexandria main hospital ( for example

antihypertensive, antidiabetic agents)

C.

Professional

and Practical

Skills

C8 Acquire the technical skills (e.g.

developing medical decision trees

c1. Acquire the technical skills (e.g.

developing medical decision trees)

C9. Interpret images/ diagram

Social/ethical skills (e.g. interpretation of

results at the population level,

understanding of ethical issues)

C10. Acquire personal/professional skills


c2. Interpret images/ diagram Social/ethical

skills (e.g. interpretation of results at the

population level, understanding of ethical

issues)

c3. Acquire personal/professional skills (e.g.

functioning within an organization)

D. General

Skills

D6. Communicate and share ideas with

professors to Use the computer aided


professors to Use the computer aided decision

decision making from drug discovery in

pharmacoeconomic

D7 Communicate and collaborate within a

team Application level (e.g. one should be

able to understand a decision tree that is

conceptualized by others)

D8. Participate in Conceptualization level

(e.g. one can develop a new decision tree)

D9. Within a team design a research

project done in Alexandria Faculty

Medicine about pharmacoeconomic of

neuropathic pain killers, antidiabetic,

antihypertensive d5. Share in completion

of a national research in Alexandria

Somuaha hospital

D10. Share in improving the quality of

practice and patient care in Alexandria

D11. Share in activities of (ISPOR=

International Society for

Pharmacoeconomics and Outcome

research)

making from drug discovery in

pharmacoeconomic


team Application level (e.g. one should be able

to understand a decision tree that is


d3. Participate in Conceptualization level (e.g.

one can develop a new decision tree)

d4. Within a team design a research project

done in Alexandria Faculty Medicine about

pharmacoeconomic of neuropathic pain killers,

antidiabetic, antihypertensive d5. Share in

completion of a national research in Alexandria

Somuaha hospital

d6. Share in improving the quality of practice

and patient care in Alexandria

d7. Share in activities of (ISPOR= International

Society for Pharmacoeconomics and Outcome

research)





E1. Show respect to professors, colleagues,




Lectures self

learning

Practical/

Clinical

Small

group

discussion

Others

1. updates in measuring costs ✓ ✓

2. methods of sensitivity analysis ✓ ✓

3. the use of data from randomized

clinical trials (RCT) versus

observation from

pharmacoeconomic study

✓

4. Critique six studies that use retrospective database

✓ ✓

5. Design/ practice a

pharmacoeconomic study that evaluate

therapeutic service in Alexandria main

hospital ( for example antihypertensive,

antidiabetic agents)

✓ ✓ ✓


Student Assessment



Case OSCE/OSPE


Others


Mid-term 30 %

End of term 70 %


Written Exam 70 %


Others %

✓

✓

✓

✓ ✓


Lecture Notes

✓

Course Text Books

• Karen L.Rasacati (2014), Essentials of

Pharmacoeconomics, 2nd ed., Wolters

Kluwer, Lippincott, William & Wilkins

Austin, Texas.

• Copeland, R. A., and Anderson, P. S. (2002),

in Textbook of Drug Design and Discovery,

3rd ed., P. Krogsgaard-Larsen, T. Liljefors,

and U. Madsen, eds., Taylor and Francis,

New York,


International Society for Pharmacoeconomics

and Outcomes Research membership


Publications of ISPOR= International Society

for Pharmacoeconomics and Outcome

research)

Egyptian Guidelines and reports for Reporting

Pharmacoeconomic Evaluations

Course Instructor


Program Coordinator

Name: Signature:


Name: Signature:



Faculty: Medicine

Department: Clinical pharmacology

Course Information

Course Code: 05060910 Course Name: Advanced toxicokinetics & Drug poisoning



Course Aims

Gain advanced knowledge and apply recent laboratory techniques that helps in understanding

the pharmacokinetic aspects of different therapeutic agents and its implications in the field of

drug poisoning and toxicology with exploration of recent guidelines in their evaluation and

management aiming to improve outcome and decrease in both drug related morbidity and

mortality.



matrix) Course ILOs

A. Knowledge

and

Understanding

A24. Discuss toxicity tests

A25. Discuss applicable lines of

management in drug poisoning.

A26. Discuss drug teratogens.

A27. Discuss drug related

A1. Discuss animal toxicity tests.

A2. Review In Vitro Alternatives to Animal Toxicity .

A3. Define toxicogenomis

A4. Review toxicokinetics.

1 2

carcinogenesis. A5. Discuss recent laboratory investigation

involved in drug related adverse reaction.

A6. Discuss in detail the specific diagnostic tool

for each drug related toxicity.

A7. Discuss general lines of management of

intoxication patient.

A8. Recognize that specific measures of each

agent with the specific antidote if available.

A10. Discuss different categories of teratogenic

drugs.

A11. Discuss optimal drug choice in pregnancy.

A12. Recognize drugs with high carcinogenic

potentials

A13. Discuss in measures to reduce the risk.

B. Intellectual

skills

B22. Explain toxicokinetics.

B23. Choose alternative drugs to avoid

potential drug interactions.

B1Assess Extent of exposure in toxicity studies

B2. Evaluate data from toxicity studies

statistically.

B3. Compare between Single-dose toxicity studies and Repeated-dose toxicity studies

B4. Select optimal drug in patient receiving

other drugs which inhibit or stimulate

metabolizing enzymes.

C.Professional

and Practical

Skills


methodology and laboratory

technology in drug research and

clinical investigations.

C1. Apply recent laboratory techniques in

clinical and analytical toxicology.

C2. Implement the quantitative evaluation of

plasma drug level in drug discovery and

development

C12. Add to the practice of the



C3. Design kinetics of different therapeutic

agents.

C4. Apply the mathematical calculations for

Steady State Analysis of plasma drug level.

D. General

Skills



or industry.

D1. Identify examples of Pharmacologically

Interesting recent advances in manipulating

drugs with high toxic risk.

D2. Acquire the ability to recognize errors in

prescribing multidrug therapy which may

interact and to correct these errors.



Lectures self

learning

Practical/

Clinical

Small

group

discussion

Others

1. Descriptive Animal Toxicity Tests

✓ ✓

2. In Vitro Alternatives to Animal Toxicity

✓ ✓

3. Toxicogenomics ✓ ✓

4. The objectives of toxicokinetics and the parameters, which may be determined

✓ ✓ ✓

5. Carcinogenic and teratogenic agents, how to minimize the risk

✓ ✓ ✓

6. Quantification of exposure

✓ ✓ ✓

7. Justification of time points for sampling

✓ ✓ ✓

8. Justification of time points for sampling

✓ ✓ ✓

9. Contribution to the setting of dose levels in order to produce

✓ ✓

adequate exposure

10. Extent of exposure assessment in toxicity studies

✓ ✓

11. Extent of exposure assessment in toxicity studies, Complicating factors in exposure interpretation, Route of administration

✓ ✓

12. Determination of metabolites

✓ ✓

13. Statistical evaluation of data

✓ ✓ ✓

14. Analytical methods ✓ ✓ ✓

15. Reporting ✓ ✓ ✓

16. Toxicokinetics in the various areas of toxicity testing - specific aspects

✓ ✓ ✓

17. Single-dose toxicity studies ✓ ✓ ✓

18. Repeated-dose toxicity studies

✓ ✓ ✓

19. Genotoxicity studies and Carcinogenicity

✓ ✓ ✓

20. Reproductive toxicity studies

✓ ✓ ✓


Student Assessment



Case OSCE/OSPE


Others

Schedule of Assessment Mid-term 30 %

✓ ✓

✓

✓

End of term 70 %


Written Exam 70 %


Others %


Lecture Notes

✓

Course Text Books

• Michael J. Derelanko (2014), Handbook of

toxicology, 3nd ed., Wiley, New York.

• Abou-Donia Mohamed B (2015), Mammalin

toxicology, 1st ed., Wiley, New York.



Course Instructor

Name: Signature:

Program Coordinator

Name: Signature:


Name: Signature:



Faculty: Medicine


Course Information

Course Code: 05060911 Course Name: Health outcomes and health-related Quality of life


Number of Credit Hours: 1 Theoretical Clinical/Practical

Course Aims to:

1. Identify the different patient-reported health outcomes and health-related quality of life

measures.

2. Emphasize on the importance of assessing health-related quality of life.

3. Appraise the reliability and validity of assessing health-related quality of life measures.

4. Distinguish common measures of health-related quality of life.

5. Develop students’ skills in assessment of :




• Health state preferences.


Program ILO Course ILOs

A. Knowledge

and

Understanding

A28 Identify patient-reported health

outcomes and health-related quality of

life measures.

A1. Define health-related quality of life.

A2.Discuss Quality-of-life outcomes

associated with pharmacotherapy.

A3.Outline and estimate measures of health-

related quality of life.

A4. Distinguish the 36-Item Short Form

Health Survey (SF-36).

A5.estimate quality-adjusted life-years

(QALY).

1

B. Intellectual

skills

B24 Apply the health outcomes and

health-related quality of life measures

to pharmacotherapy.

B1. Discriminate types of conditions and

types of treatments which determine the

value of pharmacotherapy based on

health-related quality of life measures.

B2.Distinguish Concepts of respondent

and administrative burden related to the

assessment of health-related quality of

life.

C. General ,

Professional

and Practical

Skills

C1Hold skills to critically evaluate


C1.Criticize the validity and reliability of

the measured outcomes.

C2. Design a study to assess the health-

related quality of life outcomes of

pharmacotherapy in a specific patient

population.

D. General

Skills



D2. Acquiring new communication skills in

designing and delivering talks and lectures


D1. critically evaluate evidence presented by

publications

D2. Use new communication skills in designing

and delivering talks and lectures

D3. Train in team working during group discussions









Lectures self

learning

Practical/

Clinical

Small

group

discussion

Others

1. Identify the different patient-

reported health outcomes and

health-related quality of life

✓ ✓

measures.

2. Emphasize on the importance of

assessing health-related quality

of life.

✓ ✓

3. Appraise the reliability and

validity of assessing health-

related quality of life measures.

✓ ✓

4. Distinguish common measures

of health-related quality of life.

✓ ✓

6. Develop students’ skills in

assessment of :




• Health state preferences.

✓

✓

Student Assessment



Case OSCE/OSPE


Others


Mid-term 30 %

End of term 70 %


Written Exam 70 %


Others: assignment 30 %


Lecture Notes

✓

Course Text Books


• JM Ritter, LD Lewis, TG Mant & A Ferro

(Eds.), A Textbook of Clinical Pharmacology

and Therapeutics.

✓ ✓

✓


--



• The Journal of Clinical Pharmacology

Course Instructor

Name: Signature:

Program Coordinator

Name: Signature:


Name: Signature:



Faculty: Medicine


Course Information

Course Code: 052409060 Course Name: Oncology for Clinical

pharmacology



Course Aims

By the end of this course, the student is supposed to have the proper knowledge and understanding

about the pathogenesis and criteria of carcinogenesis, the common carcinogens. He should have

detailed information about anti-neoplastic agents, their mechanisms of action, therapeutic uses,

adverse drug reactions and contra-indications. Updated information about guidelines for treatment of

common neoplastic diseases will be discussed in this course



matrix) Course ILOs

A. Knowledge

and

Understanding

A1. Discuss the pharmacology and possible

effects of a drug and integrate other

disciplines with clinical pharmacology.


pharmacokinetic concepts that will help in

understanding basic drug actions.




A6. Classify each target to different

al- Describe the pathophysiology of cancer.

including the hallmarks of cancer, the

metastatic process, tumour biology, tumour

markers, and mechanisms of resistance.

a2- Discuss the epidemiology of cancer

including various causative factors

(environmental versus non-environmental)

a3- Evaluate the role and appropriateness of

various screening methods

a4- . Identify the main treatment modalities

of cancer

a5- Categorize the different intents of

treatment with chemotherapy and radiation,

1 1

subcategories and superfamilies that have

been so far enrolled

A7. Identify linking signaling cascade of

each target and potential sites where a

drug can possibly intervene starting at cell

surface down to nuclear modulation and


A29. Review pharmacokinetic and

pharmacodynamics of

anticancer drugs

including neoadjuvant, adjuvant and

palliative treatment.

a6- Explain the rationale for combination

chemotherapy to treat various types of

cancer

a7- Explain the mechanism of action, place

in therapy and role in conjunction with

chemotherapy. of targeted therapies (e.g.,

vascular endothelial growth factor

inhibitors, epithelial growth factor receptor

inhibitors,)

a8- Discuss the chemotherapy-induced

hematological and non-hematological

adverse effects

a9- Describe the mechanism of various

adverse effects related to biologic/targeted

therapies

a10- Compare and contrast the relevant

available classes of drugs used for the

treatment of chemotherapy-induced side

effects

. a 11- Explain the normal process of

hematopoiesis

A12- Identify various disorders of abnormal

hematopoiesis

B. Intellectual

skills

B25 Analyze relevant information to

determine drug therapy

problems, urgency, and priority

for a given clinical situation

bl- Analyze relevant information to

determine drug therapy problems, urgency,

and priority for a given clinical situation

b2- Interpret various prognostic factors

related to cancer and their impact on

treatment approaches

b3- Develop and justify a therapeutic plan

with follow up for a given clinical situation

b4- Evaluate the quality, accuracy, and

completeness of the therapeutic plan

C.

Professional

and Practical

Skills



innovation

c1. demonstrate respect and collaboration in

team functioning

c2. Apply interprofessional patient centered

care principles to reach decisions for

therapeutic alternatives

c3. Acquire personal/professional skills


D. General

Skills





decision making from drug discovery in

pharmacoeconomic


team Application level (e.g. one should be

able to understand a decision tree that is








Teaching/Leang Methods

Lectures self Practical/ Small Others


learning Clinical group

discussion

1. Biology of malignant

transformation in haematopoietic

cells

✓ ✓

2. Practical issues in cytotoxic

chemotherapy usage

✓ ✓

3. Biological treatments in cancer

✓

4. Hormones in cancer

✓ ✓

5. Management of GIT cancers:

(Stomach, Colon and rectum,

Exocrine pancreas)

✓ ✓ ✓

6. Management of cancer Bladder ✓ ✓

7. Management of pulmonary

cancer

✓ ✓

8. Management of prostate cancers ✓ ✓

9. Management of CNS cancers ✓ ✓

10. Management of lymphomas and

myeloma

✓ ✓


Student Assessment



Case OSCE/OSPE


Others


Mid-term 30 %

End of term 70 %


Written Exam 70 %


Others %

✓

✓

✓

✓ ✓


Lecture Notes

✓

Course Text Books

• Katzung Basic and Clinical

Pharmacology


• JM Ritter, LD Lewis, TG Mant & A

Ferro (Eds.), A Textbook of Clinical

Pharmacology and Therapeutics.

• Harrison’s Principles of Internal

Medicine


• Abeloff's Clinical Oncology

• Skin Cancer: Recognition and

Management


International Classification of Diseases (ICD) -

Official publication of the World Health

Organization


The Journal of Clinical Pharmacology

Course Instructor

Name: Signature:

Program Coordinator

Name: Signature:


Name: Signature:

https://en.wikipedia.org/wiki/Abeloff%27s_Clinical_Oncology

https://en.wikipedia.org/wiki/Skin_Cancer:_Recognition_and_Management

https://en.wikipedia.org/wiki/Skin_Cancer:_Recognition_and_Management

https://en.wikipedia.org/wiki/International_Classification_of_Diseases

https://en.wikipedia.org/wiki/World_Health_Organization

https://en.wikipedia.org/wiki/World_Health_Organization



Faculty: Medicine


Course Information

Course Code: 050209060 Course Name: Acute Care Cardiology



Course Aims

Gain advanced knowledge in optimizing use of medications for critically ill cardiac patients and

provide advanced clinical training in the areas of critical care pharmacotherapy to develop independent

problem-solving skills . This includes the establishment of a firm knowledge base in cardiovascular

pharmacology. The course will provide an integrated approach to critical cardiovascular medicine and

focus on applying scientific principles to direct patient care.



matrix) Course ILOs

A. Knowledge

and

Understanding

A30. Understand appropriate

pharmacotherapeutic regimens in

cardiovascular diseases in critically ill

patients

A1. Explain appropriate

pharmacotherapeutic regimens in

cardiovascular diseases in critically ill

patients including cardiogenic shock,

coronary artery disease, heart failure,

valvular disease, and cardiac surgery

perioperative management

A2. Demonstrate knowledge of fundamental

approaches to the evidence-based care of

acute myocardial infarction, congestive

heart failure, unstable arrythmias , and other

0.5 0.5

critical cardiovascular problems.

A31. Recognize specific problems

of prescribing for critically ill

cardiac patient

A3. Discuss the impact of altered

hemodynamic changes on drug

pharmacokinetics.

A4. Explain principles for appropriate

prescription in critically ill patients to

avoid adverse effects, drug interactions

and minimize adverse events.

A32. Recognize guidelines for

managing critically ill cardiac

patient

A5. Review guidelines and evidence-based

practices for prescribing for critically ill

cardiac patient.

B. Intellectual

skills

B26. Apply the standards of practice

for clinical pharmacology to the

critical care practice environment using

a standard process of care.

B1. Apply the standards of practice for

clinical pharmacology to the critical care

practice environment using a standard

process of care.

B2.Develop an approach to conducting a

gap analysis relative to the principles and

values of team-based care in a local critical

care practice environment.

B27. Identify the best practice patterns

to facilitate care of the critically ill

cardiac patient

B3. Appreciate the status of several areas of

active research on cardiovascular

pharmacology.

B4. Identify the best practice patterns to

facilitate care of the critically ill cardiac

patient

C.

Professional

and Practical

Skills

C13. Evaluate the critically ill cardiac

patient condition and recommend

appropriate corresponding

C1. Interpret a patient’s hemodynamic

status and recommend appropriate

corresponding pharmacotherapeutic

pharmacotherapeutic regimens.

regimens.

C2. Evaluate patients and devise a treatment

strategy for patients with cardiogenic shock,

considering pharmacodynamic response to

vasopressors/inotropes.

C3. Optimize drug therapy in patients with

cardiovascular disease

C4.Integrate drug therapy into an overall

cardiovascular disease management plan..

C14. Correctly interpret common

electrocardiographic effects of cardiac

drugs.

C5. Correctly interpret common

electrocardiographic effects of cardiac

drugs.

D. General

Skills



D1. Provide appropriate advice to patients

and other healthcare professionals regarding

disease management, including drug

therapy.

D2.Hold skills to critically evaluate


concerning cardiovascular pharmacology.

D3. Assist in the achievement of

performance improvement projects and

goals identified by the cardiology services,

including current projects targeting the

pharmacological care of patients with

myocardial infarction and acute coronary

syndromes .

D4. Satisfy requirements for Continuing

Professional Development.

Attitudes and

ethical

behavior






patients during lectures, discussion and clinical

practice



Lectures self

learning

Practical/

Clinical

Small

group

discussion

Others

1. Pathophysiology and therapy

of Acute Coronary Syndromes

(Introduction)

✓

2. Pharmacotherapy of non-

STEMI/unstable angina

✓

3. Pharmacotherapy of STEMI

(Antithrombotic Therapy in

CV)

✓

4. Guidelines for the

Management of

supraventricular arrhythmias

✓ ✓

5. Pharmacotherapy of ventricular

arrhythmias

✓

6. Treatment of the Patient with

acute heart failure

✓

7. Drug therapy of pulmonary

embolism and DVT

✓

8. Pharmacotherapy Of

HYPERTENSIVE

emergencies

✓

9. Pharmacotherapy of shock ✓

10. Comparison of different

antithrombotics used in

critically ill patient

✓


antihypertensives used in


✓


antiarrhythmics used in


✓

13. Guidelines for safe use of

cardiovascular drugs in cardiac

emergencies

✓

14. Role of beta blockers, ACEIs,

CCBs, vasoactive drugs ad

diuretics in cardiac

emergencies

✓


Student Assessment



Case OSCE/OSPE


Others


Mid-term 30 %

End of term 70 %


Written Exam 70 %


Others %


Lecture Notes

✓

Course Text Books

• Fundamentals of cardiovascular

Pharmacology

• Textbook of Interventional

Cardiovascular Pharmacology


• Cardiac Drug Therapy | M. Gabriel Khan |

Springer

• Cardiac Drugs: Kanu Chatterjee, Eric J.,

M.D.


• Cardiovascular Pharmacology and

Therapeutics

Course Instructor

Name: Azza Baraka Signature:

Program Coordinator

Name: Signature:


Name: Samia Mohammed Ali Signature:

✓ ✓

✓

✓



Faculty: Medicine


Course Information

Course Code: 05060912 Course Name: Clinical Immunology



Course Aims

Gain advanced knowledge and clinical skills in diagnosis and treatment of immunological diseases.

Distinguish the role of drug in manipulation of the immunologic functions to suppress or stimulate

cellular and humoural immunity. Recognize the immunosuppressant drugs in organ transplantation and

probable adverse drug reactions. Discuss the genetic variation affecting drug metabolism and

disposition and its reflection on dose modulation and response to treatment.



matrix)

Course ILOs

A. Knowledge

and

Understanding

A33. Recognize Basic immunologic

Structure and Function

A1a. Discuss the development of

immunological cells.

A1b. Identify the function of immunologic

cells.

A1c. Summarize the immunologic

mediators.

A1d. Describe the regulatory mechanisms

of immune system.

A34. Recognize recent advances in

Immunodeficiency diseases

A2a. classify immunodeficiency diseases.

A2b. discuse drug treatment of Acquired

immunodeficiency disease.

A2c. Discuss adversre effects of drugs used

in treatment of HIV infection.

½ ½

A35. Discuss Recombinant Proteins

used in Immunotherapy

A3a. Discuss development of Recombinant

Proteins

A3b classify Recombinant Proteins

A3c. Explain the use of Recombinant

Proteins in therapy of immunologic

diseases.

A3d. discuss adverse effects of

Recombinant Proteins.

A36. Discuss the drugs used in

immunosuppressive therapy

A4a. classify immunosuppressive drugs

A4b. discuss the use of immunosuppressive

drugs in therapy of immunologic diseases.

A4c. discuss adverse effects of

immunosuppressive drugs.

A37. Discuss the diagnosis and

management of Allergic diseases

A5a. classify allergic diseases.

A5c. discuss the drugs used in treatment of

Allergic diseases.

A5d. discuss adverse effects of the drugs

used in treatment of Allergic diseases.

A38. Discuss the Disease-modifying

antirheumatic drugs (DMARDs)

A6a. classify allergic diseases.

A6b. discuss the drugs used in treatment of

Allergic diseases.

A6c. discuss adverse effects of the drugs

used in treatment of Allergic diseases.

A39. Discuss Autoimmune Diseases

A7a. classify Autoimmune Diseases.

A7b. discuss the Patterns of autoimmune

disease.

A7c. discuss Mechanisms of tissue damage.

A7d. discuss drug Treatment of

autoimmune disease.

A40. Discuss the role of drugs in

Transplantation immunology

A8a. Identify Histocompatibility genetics in

humans.

A8b. discuss Solid organ transplantation

and role of drugs in prevention of rejection.

A8c. discuss Haematopoietic stem cell

transplantation and role of drugs in

prevention of rejection.

B. Intellectual

skills

B28. Choose suitable drugs for

treatment of immunological

diseases .

B1a. Compare the drugs used in

immunotherapy as regard efficacy, safety,

suitability and cost.

B1b. Select optimal drug in in treatment of

immunological diseases.

B29. Choose alternative drugs to avoid

potential drug interactions.

B2a. Select optimal drug in patient with

increased activity of drug metabolizing

enzyme.

B2b. Select optimal drug in patient

receiving other drugs which inhibit or

stimulate metabolizing enzymes.

C.Professional

and Practical

Skills


laboratory investigations in drug

research and clinical diagnosis.

C1a. Apply recent laboratory techniques

diagnosis of immunological diseases

C1b. Implement the newly developed drugs

in formulation of drug regimens.

D. General

Skills



D1a. Identify examples of

Pharmacologically Interesting recent

advances in immunosuppressants.

D2. Acquire the ability to recognize errors

in prescribing multidrug therapy, which

may interact on metabolizing enzymes, and

to correct these errors.

Attitudes and

ethical

behavior


other members of medical team and

to patients



patients during lectures, discussion and clinical

practice



Lectures self

learning

Practical/

Clinical

Small

group

discussion

Others

1. Recombinant Proteins and

Immunotherapeutics

✓ ✓

2. Drug immunosuppressive therapy ✓ ✓

3. Disease-modifying antirheumatic

drugs (DMARDs)

✓

4. Basic immunology: Structure and

Function

✓ ✓

5. Infection ✓ ✓

6. Immunodeficiency (management of

HIV)

✓

7. Anaphylaxis and Allergic diseases ✓ ✓

8. Treatment of autoimmune disease ✓ ✓

9. Lymphoproliferative Disorders ✓ ✓

10. Immune Manipulation ✓

11. Transplantation immunology ✓ ✓


Student Assessment



Case OSCE/OSPE


Others

Schedule of Assessment Mid-term 30 %

End of term 70 %


Written Exam 70 %


Others %


Lecture Notes

✓

Course Text Books

• John B. Zabriskie. Essential-Clinical-

Immunology 2009.

• Harrison's PRINCIPLES OF INTERNAL

MEDICINE Seventeenth Edition



• J allergy Clin Immunol

Course Instructor

Name: Signature:

✓ ✓

✓

✓

Program Coordinator

Name: Signature:


Name: Signature:



Faculty: Medicine


Course Information

Course Code: 05060913 Course Name: Herbal use in therapy



Course Aims

Gain advanced knowledge and criticize the highly practiced herbs by Egyptian populations

concerning the international published evidence based one.

Implement national guidelines for optimal use of herb-drug in common disease interventions



matrix) Course ILOs

A. Knowledge

and

Understanding

A41. Discuss in details types,

preparations, toxicities of active

principles in herbal medicinal

plants

al- Classify types of active principles in

herbal medicinal plants

a2- Explain factors affecting efficacy or

toxicity by herbs

a3- Identify the pharmaceutically available

herbal preparations

a4- Outline methods of extraction,

purification

a5- Enumerate dosage preparations

derived from medicinal plants

0.5 0.5

a6- Interpret synergistic herbal formula

a7- outline turmeric importance in

medicine

a8-Predict the quality control in

production of herbal remedies

a9-Discuss limitations of prescribing

herbal remedies

a10- Point updated references and

websites on licensed herbal preparations

in Egypt and world wide

B. Intellectual

skills

B30 Use evidence based data to assess

the proper use of herbal preparations

bl- Judge the Safety in prescribing herbal

preparations

b2- Compare evidence based data regarding

herb drug interactions

b3- Critique three international studies done

on herbs

b4- Design/ practice pharmacologic study

evaluate efficacy or adverse effects of three

herbs

C.Professional

and Practical

Skills

C8 Acquire the technical skills (e.g.

developing medical decision trees

C9. Interpret images/ diagram

Social/ethical skills

C10. Acquire personal/professional skills

(e.g. functioning within an organization

c1. Acquire technical skills ,

developing medical decision

c2. Interpret images/ diagram /

results at the population level

c3. Acquire personal/professional

skills (e.g. functioning within an

organization)

D. General

Skills

D12. Communicate and share

ideas with professors to Use the

computer aided evidence based

data regarding herbs

D13. Communicate and

collaborate within a team able to

understand and refined food-drug

herb interaction or allergy

D14. Participate in experimental

studied

D15. Within a team design a

research project done in

Alexandria Faculty Medicine

regarding herbal or homeopathic

modulation of neuropathic pain

killers, antidiabetic,

antihypertensive

D16. Share in completion of a

national research in Alexandria

Somuaha hospital



evidence based data regarding herbs

d2. Communicate and collaborate

within a team able to understand and

refined food-drug herb interaction or

allergy

d3. Participate in experimental studied

d4. Within a team design a research

project done in Alexandria Faculty

Medicine regarding herbal or

homeopathic modulation of

neuropathic pain killers, antidiabetic,

antihypertensive

d5. Share in completion of a national

research in Alexandria Somuaha

hospital




medical team and to patients



team and to patients during lectures,

discussion and clinical practice



Lectures self

learning

Practical/

Clinical

Small

group

Others

discussion

1. Definition and history, classification according to active groups

✓ ✓

2. agency regulates the manufacture or certifies the labeling of herbal preparations

✓ ✓

3. Methods of preparation,

purification, titration

Identification practically, pharmaceutically of selected herbs 1

✓

4. Pharmacological evidence based study of each plant

✓ ✓

5. Pharmacological evidence based study of each plant (5-9)

6.

✓ ✓


Student Assessment



Case OSCE/OSPE


Others


Mid-term 30 %

End of term 70 %


Written Exam 70 %


Others %


Lecture Notes

✓

Course Text Books • Herbal drugs as therapeutic agents Analysis, 2nd ed.,

✓ ✓

✓

✓

CRC Press books. New York.

• Copeland, R. A., and Anderson, P. S. (2002), in Textbook of

Drug Design and Discovery, 3rd ed., P. Krogsgaard-Larsen,

T. Liljefors, and U. Madsen, eds., Taylor and Francis, New

York,



www.naturalpedia.com/book_ Constituents_of_Medicina...

www.journals.elsevier.com /journal-of-herbal-medicine

Course Instructor


Program Coordinator

Name: Signature:


Name: Signature:

http://www.naturalpedia.com/book_

http://www.journals.elsevier.com/

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