Journal of Pharmaceutical Investigation

The Korean Society of Pharmaceutical Sciences and Technology (한국약제학회)
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One-step Sample Size Determination for 2×2 Bioequivalence Study

2×2 생물학적 동등성 시험 적정 피험자 수의 간단한 계산 방법

  • 이영주 (경희대학교 약학대학, 경희대학교 동서약학 연구소) ;
  • 이홍재 (경희대학교 약학대학) ;
  • 김한결 (경희대학교 약학대학) ;
  • 오주희 (경희대학교 약학대학) ;
  • 신용준 (경희대학교 약학대학) ;
  • 김영지 ((주)오리엔트파마시아) ;
  • 김상년 ((주)오리엔트파마시아)
  • Published : 2009.06.20
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Abstract

There are several approaches to calculate a sample size for bioequivalence test. Among these approaches, sample sizes determination based on Schuirmann's two one-sided tests procedures has been used most popularly in case of 2${\times}$2 bioequivalence study. Here we proposed simple sample size table for conventional 2${\times}$2 bioequivalence test based on Schuirmann's two one-sided tests in accordance with Korean Guidelines for Bioequivalence Test. This table will allow researchers with a little statistical background to calculate the sample size for bioequivalence with easy process.

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References

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Cited by

  1. Considering Aspects for the Revision of Current Bioequivalence Guideline vol.39, pp.4, 2009, https://doi.org/10.4333/KPS.2009.39.4.233