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2×2 생물학적 동등성 시험 적정 피험자 수의 간단한 계산 방법
이영주,이홍재,김한결,오주희,신용준,김영지,김상년,Lee, Young-Joo,Yi, Hong-Jae,Kim, Han-Gyul,Oh, Ju-Hee,Shin, Yong-Jun,Kim, Young-Gi,Kim, Sang-Nyun 한국약제학회 2009 Journal of Pharmaceutical Investigation Vol.39 No.3
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.