Exam 1

Question 1

Phase 1

Answer 1

a pilot study of a potential drug using a small number of selected, usually healthy human volunteers

Question 2

Phase 2

Answer 2

a clinical study of a proposed drug by selected physicians using actual patients who have the disorder the drug is designed to treat; patients must provide informed consent

Question 3

Phase 3

Answer 3

use of a proposed drug on a wide scale in the clinical setting with patients who have the disease the drug is thought to treat

Question 4

Phase 4

Answer 4

continuous evaluation of a drug after it has been released for marketing
In most cases, the strictest law is the one that prevails.

Question 5

Pure Food and Drug Act:

Answer 5

Prevented the marketing of adulterated drugs; required labeling to eliminate false or misleading claims

Question 6

Federal Food, Drug, and Cosmetic Act:

Answer 6

Mandated tests for drug toxicity. Established procedures for introducing new drugs. Gave FDA the power of enforcement.

Question 7

Durham-Humphrey Amendment:

Answer 7

Tightening control of certain drugs; specified drugs to be labeled “May not be distributed without a prescription”

Question 8

Kefauver-Harris Acts:

Answer 8

Tightened control over the quality of drugs; gave FDA power over the procedure of drug investigations; stated that efficacy as well as safety of drugs had to be established

Question 9

Controlled Substances Act:

Answer 9

Defined drug abuse and classified drugs as to their potential for abuse; provided strict controls over the distribution, storage, and use of these drugs.

Question 10

Orphan Drug Act:

Answer 10

Provided incentives for the development of orphan drugs for treatment of rare diseases

Question 11

Category A drugs:

Answer 11

Adequate studies in pregnant women have not demonstrated a risk to the fetus in the first trimester of pregnancy, and there is no evidence of risk in later trimesters.

Question 12

Category B drugs:

Answer 12

Animal studies have not demonstrated a risk to the fetus, but there are no adequate studies in pregnant women, or animal studies have shown an adverse effect, but adequate studies in pregnant women have not demonstrated a risk to the fetus during the first trimester of pregnancy, and there is no evidence of risk in later trimesters.

Question 13

Category C drugs:

Answer 13

Animal studies have shown an adverse effect on the fetus, but there are no adequate studies in humans; the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks, or there are no animal reproduction studies and no adequate studies in humans.

Question 14

Category D drugs:

Answer 14

There is evidence of human fetal risk, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.

Question 15

Category X drugs:

Answer 15

Studies in animals or humans demonstrate fetal abnormalities or adverse reactions; reports indicate evidence of fetal risk. The risk of use in a pregnant woman clearly outweighs any possible benefit.

Question 16

Drug absorption:

Answer 16

what happens to a drug from the time it enters the body until it enters the circulating fluid; intravenous administration causes the drug to directly enter the circulating blood, bypassing the many complications of absorption from other routes

Question 17

Drug distribution:

Answer 17

movement of a drug to body tissues; the places where a drug may be distributed depend on the drug’s solubility, perfusion of the area, cardiac output, and binding of the drug to plasma proteins

Question 18

Half Life

Answer 18

movement of a drug to body tissues; the places where a drug may be distributed depend on the drug’s solubility, perfusion of the area, cardiac output, and binding of the drug to plasma proteins

Question 19

Pharmacodynamics:

Answer 19

How the drug affects the body

Question 20

Pharmacokinetics:

Answer 20

How the body affects on the drugs; the way the body deals with a drug, including absorption, distribution, biotransformation, and excretion