Journal of Pharmaceutical Investigation

The Korean Society of Pharmaceutical Sciences and Technology (한국약제학회)
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Considering Aspects for the Revision of Current Bioequivalence Guideline

국내 생물학적 동등성 시험 기준 개정 방향

  • Lee, Yong-Bok (College of Pharmacy, Institute of Bioequivalence and Bridging Study, Chonnam National University)
  • 이용복 (전남대학교 약학대학 부속 생물학적동등성 및 가교시험연구소)
  • Published : 2009.08.20
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Abstract

Bioequivalence (BE) studies provide important information in the overall set of data that ensure the availability of safe and effective medicines to patients and practitioners. Thus its determination of proper criterion for assessing BE is very important. BE is frequently expressed or measured by estimating area under the plasma concentration-time curve (AUC) and maximum concentration ($C_{max}$) that are reflective of systemic exposure. In all countries except Canada, the acceptance criteria of BE is that the 90% confidence interval of difference in the average values of logarithmic AUC and $C_{max}$ between test and reference products is within the acceptable range of log(0.8) ${\sim}$ log(1.25). In Canada, unlike other countries, point estimation instead of applying 90% confidence interval is applied to assess $C_{max}$ which is, in essence, more variable than AUC. We also compared other parts of BE guidelines which include a fed study, average BE (ABE), scaled-ABE, population BE (PBE), individual BE (IBE), dropout & withdrawal, sampling frequency & time and number of subjects. This article reviews the most recent BE guidelines of Korea, USA, Europe, Canada and Japan, highlighting the differences focused on Korean BE guidelines compared to other countries. It will help us to revise BE guideline of Korea reflecting international trends. Finally, it is strongly recommended that the extended acceptance criterion for the highly variable drug among all the considering aspects for the revision of current BE guideline has to be adopted into Korea BE guideline in the nearest future.

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