Ethnic Factors in New Drug Evaluations: Pharmacokinetic and Pharmacodynamic Considerations

Abstract

In recent years, there have been substantial efforts on the part of the International Conference on Harmonization (ICH) to provide guidance and/or guidelines to facilitate the registration of new drug and biologic products in the ICH regions. The objectives of these initiatives are to generate regulatory and developmental strategies that will assist in the use of a common database with limited bridging studies, when necessary, for demonstration of safety and efficacy of drugs among different ICH regions, thereby reducing regulatory burdens and promoting international harmonization of regulatory requirements.Under the auspices of ICH, the United States Food and Drug Administration recently published a draft guideline entitled “Ethnic Factors in the Acceptability of Foreign Clinical Data.” The draft guideline classifies the various ethnic or racial factors that may account for the observed differences in response to certain drugs and delineates the possible use of supplemental or bridging studies to support...