Drug Development Flashcards
1
Q
3 Stages of Drug Development
A
Pre-clinical research
Clinical Trials
New Drug Application
2
Q
A stage in drug development. Laboratory and Animal Testing To assess safety and biological activity 5000 compounds evaluated 3.5 years
A
Pre clinical research
3
Q
Phase 1, 2, 3 of Drug Development
1 Determine Safety and Dosage, 20-80 Volunteers
2 Evaluate Effectiveness, Side Effects, 100-300 Volunteers
3 Verify Effectiveness, monitor long term use reactions 1k-3k volunteers
5 enter trials
6 years
A
Clinical Trials
4
Q
Drug Development Phase Where Post marketing testing required by FDA
Phase 4 clinical trials
A
New Drug Applications