ICH E5(R1)ETHNIC FACTORS IN THE ACCEPTABILITY OF FOREIGN CLINICAL DATA

ICH E5(R1)ETHNIC FACTORS IN THE ACCEPTABILITY OF FOREIGN CLINICAL DATA

This document addresses the intrinsic characteristics of the drug recipient and extrinsic characteristics associated with environment and culture that could affect the results of clinical studies carried out in regions and describes the concept of the "bridging study" that a new region may request to determine whether data from another region are applicable to its population.