3×2 교차설계법에서 생물학적 동등성 시험의 통계분석

Abstract

A 3×2 crossover design is considered for the bioequivalence of two test formulations with a control. It could be considered as a better choice over 3×3 crossover design because of the cost and experimental duration. Oh et al.(1998) derived 3×2 crossover design and discussed its benefits over the typical crossover designs. We consider here the statistical models for 3×2 crossover design and show its statistical properties. The statistical procedures for the bioequivalence in 3×2 crossover design are shown through an example and the results are summarized by satisfying the 3 standards that proposed by the Korea Food and Drug Administration Guidelines for Bioequivalence.