Drug Evaluation and Regulation Flashcards
1
Q
Careful evaluation of the dose response relationship and pharmacokinetics
A
Phase I
2
Q
Evaluation of a drug in a moderate number of patients
A
Phase 2
3
Q
Placebo or positive control drug is included
A
Phase 2
4
Q
Comparing drugs to older therapies
A
Phase 3
5
Q
Post marketing surveillance
A
Phase 4
6
Q
Doae efficacy
A
Phase 2
7
Q
Normal volunteers, pharmacokinetics and dose sensitve acute effects
A
Phase I
8
Q
Drug is tested on a large number if patients, toxicities are observed
A
III
9
Q
Idiosyncratic reactiona are monitored
A
Phase 4
10
Q
Standard in vitro test for mutagenecity
A
Ames test
