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INTRODUCTION TO PHARMACOLOGY,

HISTORY, AND DRUG DEVELOPMENT

INSTRUCTOR: Thomas C. Westfa

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INTRODUCTION TO PHARMACOLOGY, HISTORY,AND DRUG DEVELOPMENT

INSTRUCTOR: Thomas C. Westfall O!"e#t$%es: After studying this material you should be able to: 1. Define the following terms: pharmacology; drug; pharmacodynamics;

pharmacokinetics; pharmacotherapeutics; to icology; pharmacy !. Describe the two main groups of drugs and two ma"or types of drug names #. Discuss the importance of the Drug Acts of 1$%&' 1$#( and 1$&! ). Describe the four phases of clinical trials; the *+D and +DA ,. Discuss the ma"or de-elopments that occurred during the following periods:

The /gyptian and 0abylonian eriod The eriod of 2reece and *ndia The 3oman /ra The 4iddle Ages The 4odern /ra

&. 3elate the importance of ad-ances in botany' chemistry and physiology to the

de-elopment and use of drugs 5. Describe the contribution of each of the following:

6ippocrates Claude 0ernard2alin aul /hrlichTheophrastus 3udolph 0uchheim

aracelsus 7swald 8chmiedeberg

William 6ar-ey 9ohn 9acob AbelW.A. 8erturner

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Drug any chemical agent other

than food that effects li-ingorganisms' in the medical sense' a

drug is any chemical agent used in

the treatment' cure' pre-ention or

diagnosis of disease.

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PHARMACO4INETICS Dealswith the absorption' distribution'

biotransformation and e cretion of

drugs. These factors' coupled withdosage' determine the concentration ofthe drug at its site of action and hence'

the intensity of its effects as a functionof time.

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PHARMACODYNAMICS The study of the biochemical and

physiological effects of drugs and

their mechanism of action' andstructure acti-ity relationships.

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PHARMACOTHERAPEUTICS Theuse of drugs in the pre-ention' treatmentand diagnosis of disease.

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IMPORTANT 5UESTION:

ARE DRUGS GOOD GUYS OR 6AD GUYS7

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TO8ICOLOGY That aspect of pharmacology that deals with the ad-erseeffects of drugs.

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IMPORTANT 5UESTION:

ARE DRUGS GOOD GUYS OR 6AD GUYS7

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D& 's a&e 'e(e&a / -$%$-e- $(to t3o ma$( '&o +s:

1< +on prescription drugs These are agents that may be sold=o-er the counter> ?7TC< since they are "udged safe for usewithout medical super-ision

!< rescription drugs These are agents considered to be unsafefor use e cept under super-ision and which are thereforedispensed only by the order of practitioners licensed by law to

administer them' e.g.' physicians' dentists' -eterinarians etc.

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P&o+&$eta&/ (ame @ trade name ?trade mark name<. Thisname is assigned by the manufacturer and is owned by them.While under patent protection the drug cannot be produced by

anyone else. 7nce it goes off patent' other companies maymanufacture it and the new company may gi-e it their trade name.Therefore the same drug may ha-e more than one trade name.

No(+&o+&$eta&/ (ame @ generic name. *f a drug is promising anda manufacturer wants to put it on the market' a nited 8tatesAdopted +ame ? 8A+< is selected by the 8A+ Council which is

"ointly sponsored by the American 4edical Association' theAmerican harmaceutical Association and the nited 8tates

harmacopoeia Con-ention. *f the drug is e-entually admitted tothe nited 8tates harmacopoeia' the 8A+ name becomes theofficial name.

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Befau-er 6arris Amendments ?1$&!< to the ood' Drug'and Cosmetic Act

3e uired proof of efficacy as well as safety for newdrugs and for drugs released since 1$#(; establishedguidelines for reporting of information about ad-ersereactions' clinical testing' and ad-ertising of new drugs

Comprehensi-e Drug Abuse re-ention and Control Act?1$5%<

7utlined strict controls in the manufacture' distribution'and prescribing of habit forming drugs; established

programs to pre-ent and treat drug addiction

7rphan Drug Amendments of 1$(# Amends ood' Drug' and Cosmetic Act of 1$#(' pro-iding incenti-es for de-elopment of drugs that treatdiseases with less than !%%'%%% patients in 8A

Drug rice Competition and atent 3estoration Act of1$()

Abbre-iated new drug applications for generic drugs.3e uired bioe ui-alence data. atent life e tended byamount of time drug delayed by DA re-iew process.Cannot e ceed , e tra years or e tend to more than 1)years post +D8 appro-al.

/ pedited Drug Appro-al Act ?1$$!< Allowed accelerated DA appro-al for drugs of highmedical need. 3e uired detailed postmarketing patient

sur-eillance.

rescription Drug ser ee Act ?1$$!< 4anufacturers pay user fees for certain new drugapplications. DA claims re-iew time for new chemicalentities dropped from #% months in 1$$! to !% monthsin 1$$).

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8tages of new drug de-elopment

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Time and cost profile for the disco-ery and de-elopment of a

drug candidate

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6ow drug de-elopability e periments fit into the drug disco-ery andde-elopment process.

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8cientific disciplines necessary for drug de-elopability assessment.

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T&a-$t$o(a P&o#ess Re%e&se Pha&ma#o o'/

Disease 8tate/ndogenous Eigand

3eceptor and 0iological3esponseDrug Candidate

7rphan 3eceptor /ndogenous Acti-e roducts

0iological 3esponsesDisease 8tateDrug Candidate

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A 8an rancisco opium den

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*nstantaneous cure with cocaine toothachedrops

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I9 WE WANT TO SEE AHEAD

WE MUST LOO4 6AC4

Albert 8Fent 2yorgyi

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The origins of pharmacology: religion' animals' and plants rieFe from the palace of Bing 8argon **' in Bharasabad.

4usee du Eou-re' aris' Anti uites 7rientales. ?Courtesy of 8er-ice de Documentation hotographi ue de la 4usees +ationau ' Chateau de Gersailles<

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o glo-e and deadly nightshade. These are the plant sources of digo in andatropine' respecti-ely' ?3eproduced with permission from 2eorge 2ra-es'4edicinal lants' +ew Hork: Crescent 0ooks. Copyright 1$$% 0racken 0ooks.<

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The arabic word al kuhl or alcohol. *t originally referred to one ofthe first ways of preparing drugs for e ternal use.

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The th&ee $m+o&ta(t f$' &es $( the ea& / h$sto&/ of +ha&ma#o o'/ a&e R -o f6 #he$m, Os3a - S#hm$e-e!e&', a(- oh( a#o! A!e 1 eft to &$'ht2. The/(ot o( / #&eate- (e3 a!o&ato&$es -e%ote- to the a!o&ato&/ $(%est$'at$o( of-& 's, ! t a so f$&m / esta! $she- the (e3 -$s#$+ $(e th&o 'h the t&a$($(' off t &e fa# t/, the 3&$t$(' of te0t!oo*s, a(- the fo (-$(' of s#$e(t$f$#

"o &(a s a(- so#$et$es.

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