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J Pharmacokinet Biopharm. 1990 Apr;18(2):137-44.

Power of the two one-sided tests procedure in bioequivalence.

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  • Department of Clinical and Scientific Affairs, Pfizer Pharmaceuticals, New York, New York 10017.


The power of the two one-sided tests procedure for testing bioequivalence is derived from the bivariate noncentral t distribution. Power curves are shown and their use in planning bioequivalence experiments discussed. Sample sizes computed in the usual manner from an analysis of variance are shown to be too small to assure a declaration of bioequivalence except under favorable conditions.

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[PubMed - indexed for MEDLINE]
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