Ten-year Experience of the Evaluation of Ethnic Sensitivity Data

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

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)717-724
Number of pages8
JournalDrug Information Journal
Volume45
Issue number6
DOIs
Publication statusPublished - Nov 2011

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Safety
Pharmaceutical Preparations
Pharmacokinetics
Program Evaluation
Taiwan
Extrapolation
Clinical Trials
Guidelines

Keywords

  • Asian data
  • Bridging study
  • Taiwan

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Public Health, Environmental and Occupational Health
  • Pharmacology (nursing)
  • Drug guides

Cite this

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

In: Drug Information Journal, Vol. 45, No. 6, 11.2011, p. 717-724.

Research output: Contribution to journalArticle

Hsiao, Chia Ling ; Lin, Yeong Liang ; Hsu, Li Feng ; Hsu, Kuang Yang. / Ten-year Experience of the Evaluation of Ethnic Sensitivity Data. In: Drug Information Journal. 2011 ; Vol. 45, No. 6. pp. 717-724.
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