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Determining average bioequivalence and corresponding sample sizes in general asymmetric settings. (English) Zbl 0973.62102

Summary: A new approach has been developed for bioequivalence testing to avoid impractical rejections which may occur with the commonly used W.J. Westlake’s [Biometrics 42, 741-744 (1976)] symmetric interval procedure. These methods are shown to cover the original symmetric confidence interval approach as a special case. Also, it is of considerable interest from the manufacturer’s point of view, to obtain the minimum sample size which guarantees a pre-specified power to the test. The calculation of this minimum sample size accounts for the plausible asymmetry in the equivalence range and plausible non-zero expected value of the true difference. Algorithms are provided with illustrations for both testing and sample size problems.

MSC:

62P10 Applications of statistics to biology and medical sciences; meta analysis
62F25 Parametric tolerance and confidence regions

Citations:

Zbl 0337.62025
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