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Clinical Evaluation—Therapeutics

Trials and NDA (New Drug Application)-Enabling Activities


Develop assays

Scale up for manufacturing

Evaluate reproductive toxicity

Conduct drug combination studies

Evaluate chronic toxicity

Phase 1 trial (Small human trial to evaluate safety)

Phase 2 trial (Larger human trial to evaluate safety and efficacy)

Phase 3 trial (“Definitive” assessment of safety and efficacy in a large population)

Phase 4 trial (Determine safety over time; evaluate other uses)

Support for international clinical studies

Support for Clinical Programs (information only)

DMID Clinical Research Policies and Procedures

 

Last Updated September 12, 2012