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Detecting an Outlier in 2X2 Bioequivalence Trial

2X2 생물학적 동등성 시험에서 이상치 검출을 위한 통계적 방법

  • 정규진 (한남대학교 비즈니스 통계학과) ;
  • 박상규 (중앙대학교 수학통계학부) ;
  • 우화형 (중앙대학교 수학통계학부)
  • Published : 2009.09.30

Abstract

Outlying or extreme observations are defined to be subject data for which one or more bioavailability measures are discordant with corresponding data for that subject and/or for the rest of the subjects in a study. The presence of outlying observations can have very serious consequences on the conclusions resulting from a bioequivalence study. Two statistical methods are proposed by generalizing the current well known methods and an illustrated example is presented with discussion.

생물학적 동등성 시험에서 피험자로부터 얻어진 생체 이용률 자료들 중 하나 혹은 일부가 다른 자료에 비해 크게 차이가 나는 자료를 이상치라 정의한다. 이러한 이상치의 존재는 소수의 피험자로 이루어지는 생물학적 동등성 시험의 결과에 큰 영향을 주는 것으로 알려져 있다. 생물학적 생동성 시험에서 이상치를 판별하는 통계적 방법 중 우도거리 혹은 추정량거리를 비교하는 통계적 검정이 많이 활용되고 있는데 본 연구논문에서는 이러한 통계적 방법을 보다 일반화하여 이상치를 판단하는데 보다 효율적인 검정 방법을 제안한다. 제안된 방법은 예제를 통해 자세하게 논의된다.

Keywords

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Cited by

  1. On Evaluation of Bioequivalence for Highly Variable Drugs vol.24, pp.6, 2011, https://doi.org/10.5351/KJAS.2011.24.6.1055