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. 2017 Nov 15;11(2):182–188. doi: 10.1111/cts.12520

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© 2017 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics

This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

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Clinical development strategies for drugs with new active ingredients in general global clinical trials (GCTs) and Asian GCTs. (A) The ratios of source data for the ethnic comparisons of the pharmacokinetics (PK) in the general GCTs and Asian GCTs are shown. The PK data had been collected from two sources, standard PK early‐phase studies or the late‐phase studies such as GCTs. (B) The performance ratios of exploratory trials for the Japanese population including clinical pharmacology studies in the general GCTs and Asian GCTs are shown.