(1) Intro Lecture Flashcards
1
Q
STEPS to evaluating/ comparing drugs
A
Safety Tolerance Efficacy Price Simplicity
2
Q
What’s involved in phase I of FDA drug development?
A
Phase 1: safety, PK, dose range, 20-80 unaffected subjects
3
Q
What’s involved in phase II of FDA drug development?
A
Test hypothesis of effectiveness, controlled trial, 100-300 subjects
4
Q
What’s involved in phase III of FDA drug development?
A
Randomized, blinded, placebo-controlled trials for specific indications
5
Q
What’s involved in phase IV of FDA drug development?
A
Post marketing surveillance
6
Q
Components of FDA-Approved drug label
A
Animal Pharmacology Clinical Studies Indications & Usage Contraindications Precautions Adverse Reactions Overdosage Dosage & Administration How Supplied
