Intro - Drug Development

Question 1

Phase I clinical trials are done on _______ people.

Answer 1

healthy

Question 2

Phase I trials assess what two things?

Answer 2

Safety and pharmacokinetics

Question 3

In which clinical trial phases are drugs administered to people with diasease?

Answer 3

Phases 2-4

Question 4

What did the 1994 Dietary Supplement Health and Education Act do?

Answer 4

It amended the Food, Drug and Cosmetic act to include oversight of supplements.

Question 5

What does it mean if a drug is categorized as a Class A drug?

Answer 5

It is safe during pregnancy.

Question 6

What are most drugs classified as?

Answer 6

Class B

Question 7

What class of drugs are known teratogens?

Answer 7

Class X

Question 8

Cocaine is a Massachusetts Schedule __ drug. What are the characteristics of this drug class?

Answer 8

I. These drugs have high potential for abuse and no clinical use.

Question 9

Name an example of a Massachusetts Schedule II drug and explain why.

Answer 9

Oxycontin. Has high potential for abuse but does have clinical use.

Question 10

According to Massachusetts classification, what are most drugs classified as?

Answer 10

Schedule VI

Question 11

What piece of legislation required testing for drug safety and efficacy (3 phases of testing evolved) and strengthened drug safety oversight?

Answer 11

The 1962 Kefauver-Harris Amendment to Food, Drug & Cosmetic Act

Question 12

What did the 1992 Prescription Drug User Fee Act (PDUFA) do?

Answer 12

Decreased new drug review time from 3 to 1.5 years and required drug manufacturers to pay fees to the FDA for product applications and other services

Question 13

What testing do generic versions of drugs undergo before they are approved?

Answer 13

Testing that demonstrates comparable rate and extent of absorption between the generic and brand name drugs