Power of the two one-sided tests procedure in bioequivalence
- Kem F. Phillips
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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.
- Bioequivalence Task Force. Report on recommendations from the bioequivalence hearing conducted by the Food and Drug Administration, September 29–October 1, 1986.
- D. J. Schuirmann. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability.J. Pharmacokin. Biopharm. 15:657–680 (1987).
- W. W. Hauck and S. Anderson. A new statistical procedure for testing equivalence in two-group comparative bioavailability trials.J. Pharmacokin, Biopharm. 12:83–91 (1984).
- R. E. Odeh and D. B. Owen.Tables for Normal Tolerance Limits, Sampling Plans, and Screening, Marcel Dekker, New York, 1980.
- D. B. Owen, A special case of a noncentralt-distribution.Biometrika 52:437–446 (1965).
- SAS.SAS User's Guide: Basics, Version 5, SAS Institute, Cary, NC, 1985.
- W. J. Westlake. The design and analysis of comparative blood-level trials. In J. Swarbrick (ed.),Current Concepts in the Pharmaceutical Sciences, Dosage Form Design and Bioavailability, Lea & Febiger, Philadelphia, 1973, pp. 149–179.
- Power of the two one-sided tests procedure in bioequivalence
Journal of Pharmacokinetics and Biopharmaceutics
Volume 18, Issue 2 , pp 137-144
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- Kluwer Academic Publishers-Plenum Publishers
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- hypothesis testing
- sample size
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- Kem F. Phillips (1)
- Author Affiliations
- 1. Department of Clinical and Scientific Affairs, Pfizer Pharmaceuticals, 235 East 42nd Street, 10017, New York, New York