On sample size calculation in bioequivalence trials.
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.
Chow
S C
SC
StatPlus, Inc., 1790 Yardley-Langhorne Road, Yardley, Pennsylvania 19067, USA.
Wang
H
H
D002986:Clinical Trials as Topic / Q000379:methods*; D018592:Cross-Over Studies; D006801:Humans; D018401:Sample Size; D013810:Therapeutic Equivalency