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Flashcards in Topic 1 Deck (23):
1

What is a drug?

Any chemical, other than food that affects living organisms. In medicine, a chemical agent used in treatment, cure, prevention, or diagnosis of disease.

2

Pharmacodynamics

Study of actions and mechanisms of drugs. Determines the effect of a certain concentration of a drug at site.

3

Pharmacokinetics

Study of absorption, distribution, localization in tissues, excretion, and metabolism of drugs. Determines concentration of drug at site.

4

Pharmacotherapeutics

Study of the clinical or therapeutic use of drugs to diagnose, treat, prevent, cure diseases

5

Toxicology

Concerned with adverse effects of drugs and poisonous substances.

6

Proprietary name

Trade name.

7

Nonproprietary name

Generic name. Assigned by AMA, USAN, etc.

8

Pure Food and Drug Act

1906. Governed labeling of drugs.

9

Food Drug and Cosmetic Act

1938. Sulfanimide in Diethylene Glycol. New Drug Application (NDA) required. Proof of safety.

10

Harris-Kefauver Amendments

1962. Thalidomide. Research in animals before humans (investigation new drug (IND)). 3 phases before NDA. Proof of efficacy.

11

Orphan Drug Amendments

1983. Incentives for developing drugs treating <200,000.

12

Expedited Drug Approval Act

1992. Accelerated approval if medical need high. Company pays extra.

13

Approaches to identify New Drug candidates

1.Chemical modification of known molecule-Thiazide Diuretics
2. Random Screening-Antibiotics, cyclosporine
3. Rational drug design, make a drug to fit in receptor-H2 Antagonists
4. Biotechnology and cloning genes-Recombinant tissue plasminogen activator.

14

Reverse pharmacology

Start with receptor then to disease state then to drug instead of starting with disease state.

15

Limitations of Pre-clinical testing

Time consuming expensive; lots of animals; animal to human doesn't extrapolate; rare adverse effects not detected.

16

IND requirements

Info on composition, source of drug; manufacturing info; animal studies data; clinical plans/protocols; names and credentials of physicians

17

Phase 1

Normal volunteers (20-200); mainly safety; months

18

Phase 2

Selected patients (up to several hundred). Short term safety, dosage, effectiveness; months to 2 years.

19

Phase 3

Selected patients (hundreds to thousands); safety, dosage, effectiveness; 1-4 years; gets really expensive at this phase.

20

FDA course of action on NDA

Not approvable, approvable, approval

21

Confounding Factors in clinical trials

Variable natural history of diseases; presence of other diseases/risk factors; subject and observer bias.

22

Controlled Substance Schedules

I-Highly addictive, no medical use.
II-Highly addictive, known medical use
III-V. Less addictive, known medical use.

23

Drug History

Egypt-Ebery papyrus-1500 BC

Greece-Galen 131 AD-4 humors-tincture of opium and morphine (galenicals).

Rome-Hospitals, medical schools, no new develop.

Middle Ages-Arabian apothecaries->Europe and monks

Paracelcus-1500s-disproved galen. Only the dose that makes a poison, Body made of chemicals

William Harvey-around 1600-Circulation of blood and intravenous drugs

Rudolph Buchheim-Estonia-1820-1879
Oswald Schmiedberg-1838-1921
John Jacob Abel-Student of Schmiedberg-Father of American Pharmacology.