Clinical Trials Flashcards
1
Q
Phase 1
A
20-100 (healthy, w/o targeted disease)
Gradually increase doses
1 year
2
Q
Phase 1 (goal)
A
Assess safety, obtain general pharmacokinetic data
3
Q
Phase 2
A
100-500 (w/ targeted disease)
Vary dose and method of administration
2 years
4
Q
Phase 2 (goal)
A
evaluate effectiveness
further check on safety
5
Q
Phase 3
A
1000-5000 patients
Broader patient profile
length depends on therapeutic area
6
Q
Phase 3 (goal)
A
Confirm efficacy and safety
7
Q
After Phase 3
A
New Drug Application submission and review
= 6 months for priority review to several years for standard review
8
Q
Phase 4
A
post-marketing surveillance (how the drug is doing after the marketing)
