Sankhya: The Indian Journal of Statistics

2000, Volume 62, Series B, Pt. 1, 162--174

DETERMINING AVERAGE BIOEQUIVALENCE AND CORRESPONDING SAMPLE SIZES IN GENERAL ASYMMETRIC SETTINGS

By

SAURABH MUKHOPADHYAY,

and

JAMES A. BOLOGNESE, Merck Research Laboratories, Rahway

SUMMARY. A new approach has been developed for bioequivalence testing to avoid impractical rejections which may occur with the commonly used Westlake's (1972) 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.

AMS (1991) subject classification. 62F25, 62F03

Key words and phrases. Bioequivalence; clinical trials; confidence intervals; crossover design; minimum sample size.

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