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http://dx.doi.org/10.4333/KPS.2009.39.3.217

One-step Sample Size Determination for 2×2 Bioequivalence Study  

Lee, Young-Joo (College of Pharmacy, Kyung Hee University, Kyung Hee East-West Pharmaceutical Research Institute, Kyung Hee University)
Yi, Hong-Jae (College of Pharmacy, Kyung Hee University)
Kim, Han-Gyul (College of Pharmacy, Kyung Hee University)
Oh, Ju-Hee (College of Pharmacy, Kyung Hee University)
Shin, Yong-Jun (College of Pharmacy, Kyung Hee University)
Kim, Young-Gi (Orient Pharmacia Inc.)
Kim, Sang-Nyun (Orient Pharmacia Inc.)
Publication Information
Journal of Pharmaceutical Investigation / v.39, no.3, 2009 , pp. 217-219 More about this Journal
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.
Keywords
Bioequivalence; Sample size; Statistical power;
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