intro to pharm

Question 1

define pharmacokinetics

Answer 1

deals with the absorption, distribution, metabolism and excretion of drugs

what the body does to the drugs

Question 2

pharmacodymanics

Answer 2

the study of the molecular, biochemical, and physiological effects of drugs on cellular systems and their mechanisms of action

what the drugs do to the body

Question 3

Pure food and drug act of 1906

Answer 3

Proof of efficacy not required
Proof of safety not required
Required proper labeling
Limited interstate transport of misbranded/adulterated drugs
Led to the creation of the Food and Drug Administration (FDA)

Question 4

Food, Drug and Cosmetic Act of 1938

Answer 4

Driven by the death of more than 100 children due to a sulfanilamide medication containing diethylene glycol (Massengill Company)
Proof of safety was required
Toxicity testing required in animals
Proof of efficacy not required
A new drug application (NDA) had to be filed with the FDA prior to approval

Question 5

Harris-Kefauver Amendment (1962)

Answer 5

Both efficacy and safety must be proven
Required documentation of risk to benefit ratio
Gave the FDA authority to regulate advertising
Began to classify all pre-1962 drugs already on the market as effective, ineffective or needing further study.