ICH E5(R1) Ethnic factors in the acceptability of foreign clinical data - questions and answers

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Questions and answers

Reference numberCPMP/ICH/5746/03
Published01/06/2006
Effective from01/06/2006
KeywordsForeign clinical data, regulatory requirements, extrapolation, ethnic factors, bridging study, global development
DescriptionThis document answers questions concerning the issues addressed in the ICH E5 (R1) ethnic factors in the acceptability of foreign clinical data.

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