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Ten-year Experience of the Evaluation of Ethnic Sensitivity Data

Abstract

Because ethnic factors may affect a drug’s eff-cacy and safety, bridging study evaluations (BSEs) were introduced in 2001 to assess the suitability of extrapolating foreign data during registration of a drug in Taiwan. The BSE program, based on the International Conference on Harmonization E5 guideline, may allow further clinical trials to be waived if favorable safety and extrapolation data are presented by the drug sponsor. For this study, 366 cases were collected, grouped according to categories and analyzed for rate of successful bridging study waivers. We defned one drug as one case regardless of the number of BSE submissions, and determined the rate of overall bridging study waivers to be 73.8%. The percentage of waivers in each category was studied. Several reasons for unsuccessful frst-submission BSE waivers were indentifed. Complete clinical data containing Asian pharmacokinetic data and clinical effcacy data were present in many successful bridging studies. Under some conditions, it is satisfactory that ethnic concerns for safety and effcacy might be answered by a phase 4 study.

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Author information

Correspondence to Kuang-Yang Hsu.

Additional information

The authors report no relevant relationships to disclose

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Hsiao, C., Lin, Y., Hsu, L. et al. Ten-year Experience of the Evaluation of Ethnic Sensitivity Data. Ther Innov Regul Sci 45, 717–724 (2011). https://doi.org/10.1177/009286151104500507

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Keywords

  • Bridging study
  • Taiwan
  • Asian data