Topic 1

Question 1

What is a drug?

Answer 1

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

Question 2

Pharmacodynamics

Answer 2

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

Question 3

Pharmacokinetics

Answer 3

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

Question 4

Pharmacotherapeutics

Answer 4

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

Question 5

Toxicology

Answer 5

Concerned with adverse effects of drugs and poisonous substances.

Question 6

Proprietary name

Answer 6

Trade name.

Question 7

Nonproprietary name

Answer 7

Generic name. Assigned by AMA, USAN, etc.

Question 8

Pure Food and Drug Act

Answer 8

1906. Governed labeling of drugs.

Question 9

Food Drug and Cosmetic Act

Answer 9

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

Question 10

Harris-Kefauver Amendments

Answer 10

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

Question 11

Orphan Drug Amendments

Answer 11

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

Question 12

Expedited Drug Approval Act

Answer 12

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

Question 13

Approaches to identify New Drug candidates

Answer 13

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.

Question 14

Reverse pharmacology

Answer 14

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

Question 15

Limitations of Pre-clinical testing

Answer 15

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

Question 16

IND requirements

Answer 16

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

Question 17

Phase 1

Answer 17

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

Question 18

Phase 2

Answer 18

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

Question 19

Phase 3

Answer 19

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

Question 20

FDA course of action on NDA

Answer 20

Not approvable, approvable, approval

Question 21

Confounding Factors in clinical trials

Answer 21

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

Question 22

Controlled Substance Schedules

Answer 22

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

Question 23

Drug History

Answer 23

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.