ICH E5 (R1) Ethnic factors in the acceptability of foreign clinical data

Current effective version

PDF iconAdopted guideline

Reference numberCPMP/ICH/378/95
Published01/09/1998
Effective from01/09/1998
KeywordsForeign clinical data, regulatory requirements, extrapolation, ethnic factors, bridging study, global development
DescriptionThis document recommends a framework for evaluating the impact of ethnic factors upon a medicine's effect, i.e., its efficacy and safety at a particular dosage and dose regimen. Read together with questions and answers.

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