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Biometrika 1999 86(2):395-402; doi:10.1093/biomet/86.2.395
© 1999 by Biometrika Trust
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Statistical tests for multivariate bioequivalence

W WangA1, JT Gene HwangA2 and A DasguptaA3

A1 Department of Mathematics and Statistics, Wright State University, Dayton, OH 45435, USA E-mail: wwang@math.wright.edu A2 Department of Statistical Science, Cornell University, Ithaca, NY 14853, USA E-mail: hwang@math.cornell.edu A3 Department of Statistics, Purdue University, West Lafayette, Indiana 47907, USA E-mail: dasgupta@stat.purdue.edu

Although the U.S. Food and Drug Administration (FDA, 1992) recommends testing bioequivalence of individual pharmacokinetic parameters one at a time, it seems reasonable and interesting to conduct a test simultaneously for all the parameters. In this paper, we discuss several ways to construct such tests. It is shown that the confidence set approach leads to a test which can be uniformly improved by the intersection of Schuirmann's two one-sided tests procedure. The latter test can further be improved upon noticeably by using the one-dimensional unbiased test of Brown, Hwang & Munk (1997). Numerical calculations of powers are given to support this claim.

Key Words: Confidence set; Intersection-union method; Likelihood-ratio test.


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