A Note on Sample Size Determination for Bioequivalence Studies with Higher-Order Crossover Designs
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Similar to Liu and Chow, approximate formulas for sample size determination are derived based on Schuirmann's two one-sided tests procedure for bioequiealence studies for the additive and the multiplicative models under various higher order crossover designs for comparing two formulations of a drug product. The higher order crossover designs under study include Balaam's design, the two-sequence dual design, and two four-period designs (with two and four sequences), which are commonly used for assessment of bioequivalence between formulations. The derived formulas are simple enough to be carried out with a pocket calculator. The number of subjects required for each of the four higher order designs are tabulated for selected powers and various parameter values.
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- 5.S. C. Chow and J. P. Liu. Current issues in bioequivalence trials. Drug Inform. J. 29:795–804 (1995).Google Scholar