The Korean Journal of Applied Statistics (응용통계연구)

The Korean Statistical Society (한국통계학회)
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On Evaluation of Bioequivalence for Highly Variable Drugs

변이가 큰 약물의 생물학적 동등성 평가에 관한 연구

  • Jeong, Gyu-Jin (Department of Business Statistics, Hannam University) ;
  • Park, Sang-Gue (Department of Applied Statistics, Chung-Ang University)
  • 정규진 (한남대학교 비즈니스통계학과) ;
  • 박상규 (중앙대학교 응용통계학과)
  • Received : 20110900
  • Accepted : 20111100
  • Published : 2011.12.31
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Abstract

This paper reviews the definition of highly variable drug(HVD), the present regulatory recommendations and the approaches proposed in the literature to deal with the bioequivalence issues of HVD. The concept and the statistical approach of scaled average bioequivalence(SABE) is introduced and discussed with the current regulatory methods. The recommendations for SABE approach are proposed and the further study topics related to HVDs are also presented.

본 논문에서는 변이가 큰 약물(HVD)의 생동성 평가 문제와 이를 해결하기 위하여 지금까지 수행된 연구 결과들을 소개한다. 우리나라를 비롯한 세계 여러 나라에서 현재 사용하는 전통적 생동성 평가규정 중에서 HVD에 적용 가능한 방법들과 HVD 문제 해결을 주된 목적으로 고안된 방법들로 나누어 살펴본다. 특히 scaled average bioequivalence(SABE)에 대한 연구 결과들을 통계학적인 관점에서 검토하며 SABE를 이용하여 수행하는 생동성 평가 방법에 대해 알아보고 추후 연구주제 등에 대해서도 논의한다.

Keywords

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