Ten-year Experience of the Evaluation of Ethnic Sensitivity Data

Chia Ling Hsiao, Yeong Liang Lin, Li Feng Hsu, Kuang Yang Hsu

研究成果: 雜誌貢獻回顧型文獻

摘要

Because ethnic factors may affect a drug's efficacy 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 defined 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 first-submission BSE waivers were indentified. Complete clinical data containing Asian pharmacokinetic data and clinical efficacy data were present in many successful bridging studies. Under some conditions, it is satisfactory that ethnic concerns for safety and efficacy might be answered by a phase 4 study.

原文英語
頁(從 - 到)717-724
頁數8
期刊Therapeutic Innovation & Regulatory Science
45
發行號6
DOIs
出版狀態已發佈 - 十一月 2011

指紋

Safety
Pharmaceutical Preparations
Pharmacokinetics
Program Evaluation
Taiwan
Extrapolation
Clinical Trials
Guidelines

ASJC Scopus subject areas

  • Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
  • Public Health, Environmental and Occupational Health
  • Pharmacology (medical)

引用此文

Ten-year Experience of the Evaluation of Ethnic Sensitivity Data. / Hsiao, Chia Ling; Lin, Yeong Liang; Hsu, Li Feng; Hsu, Kuang Yang.

於: Therapeutic Innovation & Regulatory Science, 卷 45, 編號 6, 11.2011, p. 717-724.

研究成果: 雜誌貢獻回顧型文獻

Hsiao, Chia Ling ; Lin, Yeong Liang ; Hsu, Li Feng ; Hsu, Kuang Yang. / Ten-year Experience of the Evaluation of Ethnic Sensitivity Data. 於: Therapeutic Innovation & Regulatory Science. 2011 ; 卷 45, 編號 6. 頁 717-724.
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