Phase II Clinical Trial
Studies in 100-300 patients with the target disease to evaluate efficacy, optimal dosing, and safety. Phase IIa is proof-of-concept; Phase IIb determines dose-response. Highest attrition rate in development.
Örnekler
- Randomized controlled trials
- Adaptive trial designs
- Go/no-go decision point
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Studies in 100-300 patients with the target disease to evaluate efficacy, optimal dosing, and safety. Phase IIa is proof-of-concept; Phase IIb determines dose-response. Highest attrition rate in development.