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E 5 (R1) Ethnic Factors in the Acceptability of Foreign ...
www.ema.europa.eudocument, ethnic factors are defined as those factors relating to the genetic and physiologic (intrinsic*) and the cultural and environmental (extrinsic*) characteristics of a population (Appendix A). 1.1 Objectives • To describe the characteristics of foreign clinical data that will facilitate their
ETHNIC FACTORS IN THE A OF FOREIGN CLINICAL D E5(R1)
database.ich.orgethnic factors* upon a medicine’s effect, i.e., its efficacy and safety at a particular dosage* and dose regimen*. It provides guidance with respect to regulatory and development strategies that will permit adequate evaluation of the influence of ethnic factors while minimizing duplication of clinical studies and supplying medicines