137k views
3 votes
Key Aspects of a Phase 2 Clinical Trial

User Poliquin
by
8.0k points

1 Answer

5 votes

Final answer:

Phase 2 clinical trials assess dose/exposure response and establish effective doses for Phase 3 trials. They gather data on safety and efficacy, involving multiple sites and patient populations. Pharmacokinetic analysis evaluates the drug's behavior in specific patient groups.

Step-by-step explanation:

The key aspects of a Phase 2 clinical trial involve assessing the dose/exposure response and establishing the effective doses for Phase 3 clinical trials. Phase 2 trials aim to gather further information on safety and efficacy of a drug, typically involving hundreds of patients at multiple sites worldwide. Pharmacokinetic analysis is conducted to evaluate the drug's behavior in specific patient populations, such as those with impaired renal or hepatic functions, as well as pediatric and elderly populations.

User Flatlineato
by
7.6k points