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Comparative Study
. 1990 Apr;18(2):137-44.
doi: 10.1007/BF01063556.

Power of the two one-sided tests procedure in bioequivalence

K F Phillips  1
Affiliations
Comparative Study

Power of the two one-sided tests procedure in bioequivalence

K F Phillips. J Pharmacokinet Biopharm. 1990 Apr.

Abstract

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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References

    1. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80 - PubMed
    1. J Pharmacokinet Biopharm. 1984 Feb;12(1):83-91 - PubMed

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