Clinical Trial Phases

Определение

The sequential stages of testing a new drug in humans. Phase I tests safety in 20-100 healthy volunteers. Phase II tests efficacy in 100-300 patients. Phase III confirms efficacy in 1,000-3,000+ patients (pivotal trials for FDA approval). Phase IV conducts post-marketing surveillance after approval.

Связанные Термины

Упоминается в Руководствах

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