Phase 1 Study

Example Definitions of "Phase 1 Study"
Phase 1 Study. A study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as further defined in 21 C.F.R. ยง 312.21(a) (or the non-United States equivalent thereof)
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