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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Chow, SC., Wang, H. On Sample Size Calculation in Bioequivalence Trials. J Pharmacokinet Pharmacodyn 28, 155–169 (2001). https://doi.org/10.1023/A:1011503032353
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DOI: https://doi.org/10.1023/A:1011503032353