On Sample Size Calculation in Bioequivalence Trials |
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Authors: | Shein-Chung Chow Hansheng Wang |
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Institution: | StatPlus, Inc., 1790 Yardley-Langhorne Road, Yardley, Pennsylvania 19067, USA. |
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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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Keywords: | crossover design parallel design normal distribution lognormal distribution log transformation robust |
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