Stages Of Drug Development Flashcards
1
Q
What is meant by Phase 1 Trials?
A
Normal, healthy volunteers
Purpose: to determine the safety and pharmacokinetic properties in humans
2
Q
What is meant by Phase 2 Trials?
A
Small group 100-250 people
Purpose: to evaluate efficacy, optimum dose, safety and side effects
3
Q
What is meant by Phase 3 Trials?
A
Typically more than 1,000 people
The drug’s efficacy and safety should be tested against a placebo
If successful, the drug must be registered by the authorities prior to being released to the market
