Drug Evaluation and Regulation

Question 1

Careful evaluation of the dose response relationship and pharmacokinetics

Answer 1

Phase I

Question 2

Evaluation of a drug in a moderate number of patients

Answer 2

Phase 2

Question 3

Placebo or positive control drug is included

Answer 3

Phase 2

Question 4

Comparing drugs to older therapies

Answer 4

Phase 3

Question 5

Post marketing surveillance

Answer 5

Phase 4

Question 6

Doae efficacy

Answer 6

Phase 2

Question 7

Normal volunteers, pharmacokinetics and dose sensitve acute effects

Answer 7

Phase I

Question 8

Drug is tested on a large number if patients, toxicities are observed

Answer 8

III

Question 9

Idiosyncratic reactiona are monitored

Answer 9

Phase 4

Question 10

Standard in vitro test for mutagenecity

Answer 10

Ames test