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.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
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.
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Phillips, K.F. Power of the two one-sided tests procedure in bioequivalence. Journal of Pharmacokinetics and Biopharmaceutics 18, 137–144 (1990). https://doi.org/10.1007/BF01063556
Received:
Revised:
Published:
Issue Date:
DOI: https://doi.org/10.1007/BF01063556