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 journalReview article

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
JournalTherapeutic Innovation & Regulatory Science
Volume45
Issue number6
DOIs
Publication statusPublished - 2011

Fingerprint

Safety
Pharmaceutical Preparations
Program Evaluation
Taiwan
Pharmacokinetics
Clinical Trials
Guidelines

Keywords

  • Asian data
  • Bridging study
  • Taiwan

ASJC Scopus subject areas

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

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: Therapeutic Innovation & Regulatory Science, Vol. 45, No. 6, 2011, p. 717-724.

Research output: Contribution to journalReview article

Hsiao, Chia Ling ; Lin, Yeong Liang ; Hsu, Li Feng ; Hsu, Kuang Yang. / Ten-year Experience of the Evaluation of Ethnic Sensitivity Data. In: Therapeutic Innovation & Regulatory Science. 2011 ; Vol. 45, No. 6. pp. 717-724.
@article{a83d98c3fe7b42a5a9f749133aa988c3,
title = "Ten-year Experience of the Evaluation of Ethnic Sensitivity Data",
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.",
keywords = "Asian data, Bridging study, Taiwan",
author = "Hsiao, {Chia Ling} and Lin, {Yeong Liang} and Hsu, {Li Feng} and Hsu, {Kuang Yang}",
year = "2011",
doi = "10.1177/009286151104500507",
language = "English",
volume = "45",
pages = "717--724",
journal = "Therapeutic Innovation and Regulatory Science",
issn = "2168-4790",
publisher = "SAGE Publications Inc.",
number = "6",

}

TY - JOUR

T1 - Ten-year Experience of the Evaluation of Ethnic Sensitivity Data

AU - Hsiao, Chia Ling

AU - Lin, Yeong Liang

AU - Hsu, Li Feng

AU - Hsu, Kuang Yang

PY - 2011

Y1 - 2011

N2 - 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.

AB - 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.

KW - Asian data

KW - Bridging study

KW - Taiwan

UR - http://www.scopus.com/inward/record.url?scp=84993778158&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84993778158&partnerID=8YFLogxK

U2 - 10.1177/009286151104500507

DO - 10.1177/009286151104500507

M3 - Review article

VL - 45

SP - 717

EP - 724

JO - Therapeutic Innovation and Regulatory Science

JF - Therapeutic Innovation and Regulatory Science

SN - 2168-4790

IS - 6

ER -