On Sample Size Determination of Bioequivalence Trials

  • Published : 2007.04.30


Sample size determination plays an important role in designing a bioequivalence trial. Formulae of sample sizes based on Schuirmann's two one-sided tests procedures are given for bioequivalence studies with the $2{\times}2$ crossover design and two-sample parallel design. A practical discussion for the relationship among these formulae is given.