Drug Development Phases

Question 1

Preclinical research

Answer 1

Drug is identified/synthesized & data is collected for human testing approval by the FDA, usually by animal testing to evaluate the pharmacological & toxicological effects
FDA regulations: assurance of good lab practice

Question 2

IND application submission

Answer 2

Application submitted to the FDA for approval off human clinical testing w/ the IND

Question 3

Phase 1 Clinical research

Answer 3

Define initial parameters of toxicity, tolerated dose range, general pharmacokinetic & pharmacodynamics data, usually small numbers (10-80 subjects)
FDA regulations: ensure subjects are not exposed to unreasonable risks

Question 4

Phase 2 Clinical research

Answer 4

Assess therapeutic effectiveness, identify common adverse effects & develop a rational dosing strategy, usually several hundred subjects w/ target disease, but w/o concomitant diseases
FDA regulation: scientific merit

Question 5

Phase 3 clinical research

Answer 5

Document effectiveness fro specific disease indications & clinical safety, usually several thousand subjects
FDA regulations: ensure research content leads to drug approval

Question 6

NDA

Answer 6

Data accumulated under IND is compiled for NDA & submitted for review & approval by FDA for specific indications

Question 7

Post marketing surveillance

Answer 7

FDA requires that postmarketing adverse events be recorded & reported, may involve phase 4 studies designed to evaluate drug effectiveness & clinical safety