Power of the two one-sided tests procedure in bioequivalence |
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Authors: | Kem F Phillips |
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Institution: | (1) Department of Clinical and Scientific Affairs, Pfizer Pharmaceuticals, 235 East 42nd Street, 10017 New York, New York |
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Abstract: | The power of the two one-sided tests procedure for testing bioequivalence is derived from the bivariate noncentral tdistribution. 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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Keywords: | bioequivalence hypothesis testing power sample size |
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