Drug Evaluation and Regulation Flashcards Preview

Topnotch Pharmacology (Sept 2017) > Drug Evaluation and Regulation > Flashcards

Flashcards in Drug Evaluation and Regulation Deck (10):
1

Careful evaluation of the dose response relationship and pharmacokinetics

Phase I

2

Evaluation of a drug in a moderate number of patients

Phase 2

3

Placebo or positive control drug is included

Phase 2

4

Comparing drugs to older therapies

Phase 3

5

Post marketing surveillance

Phase 4

6

Doae efficacy

Phase 2

7

Normal volunteers, pharmacokinetics and dose sensitve acute effects

Phase I

8

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

III

9

Idiosyncratic reactiona are monitored

Phase 4

10

Standard in vitro test for mutagenecity

Ames test