1. One-step Sample Size Determination for 2×2 Bioequivalence Study
- Author
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Hong-Jae Yi, Young-Joo Lee, Sang-Nyun Kim, Ju-Hee Oh, Han-Gyul Kim, Young-Gi Kim, and Yong-Jun Shin
- Subjects
Bioequivalence study ,Simple sample ,Sample size determination ,Statistics ,Bioequivalence ,Statistical power ,Mathematics - 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 22 bioequivalence study. Here we proposed simple sample size table for conventional 22 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.
- Published
- 2009
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