E5(R1): Ethnic Factors in the Acceptability of Foreign Clinical Data

Regulatory Resource: E5(R1): Ethnic Factors in the Acceptability of Foreign Clinical Data

Description:

The tripartite harmonised ICH guideline was finalised (Step 4) in February 1998. 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.

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