study phase
- Guideline or reference source
- DIAEDM Guide to the DIA EDM reference model, process zone regulatory submissions
- Definition
- Categorization of clinical studies based on the objectives of the study. Generally, Phase 1 studies are designed to determine dosing and safety in healthy subjects; Phase 2 studies are designed to assess safety at recommended doses and to begin to establish primary efficacy; Phase 3 studies are designed to evaluate safety and efficacy at recommended doses in patient populations for the indication being evaluated.
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