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On sample size calculation in bioequivalence trials.

S C Chow·H Wang
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Abstract

Sample size calculation plays an important role in bioequivalence trials. In practice, a bioequivalence study is usually conducted under a crossover design or a parallel design with raw data or log-transformed data. In this paper, we discuss the differences in sample size calculation between a crossover design and a parallel design with raw data or log-transformed data. Formulas for sample size calculation under a crossover design and a parallel design with raw data or log-transformed data are derived. A brief discussion for the relationship among these formulas is given.

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Clinical Trials as TopicCross-Over StudiesHumansSample SizeTherapeutic EquivalencyComparative StudyJournal Article

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S C Chow, H Wang. 2001. On sample size calculation in bioequivalence trials.. https://doi.org/10.1023/a%3A1011503032353

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