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KMID : 0369820090390030217
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Jorunal of Korean Pharmaceutical Sciences
2009 Volume.39 No. 3 p.217 ~ p.219
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One-step Sample Size Determination for 2×2 Bioequivalence Study
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Lee Young-Joo
Oh Ju-Hee
Kim Sang-Nyun
Yi Hong-Jae
Kim Han-Gyul
Shin Yong-Jun
Kim Young-Gi
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Abstract
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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 2×2 bioequivalence study. Here we proposed simple sample size table for conventional 2×2 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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KEYWORD
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Bioequivalence, Sample size, Statistical power
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