Journal
JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS
Volume 28, Issue 2, Pages 155-169Publisher
KLUWER ACADEMIC/PLENUM PUBL
DOI: 10.1023/A:1011503032353
Keywords
crossover design; parallel design; normal distribution; lognormal distribution; log transformation; robust
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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 ol 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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