A comparison of the Two One-Sided Tests Procedure and the Power Approach for assessing the equivalence of average bioavailability
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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).
W. J. Westlake. Response to T. B. L. Kirkwood: Bioequivalence testing-a need to rethink.Biometrics 37:589–594 (1981).
S. Anderson and W. W. Hauck. A new procedure for testing equivalence in comparative bioavailability and other clinical trials.Comm. Stat. A 12:2663–2692 (1983).
D. M. Rocke. On testing for bioequivalence.Biometrics 40:225–230 (1984). (See also Correspondence inBiometrics 4:561–563 (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 and Febiger, Philadelphia, 1973, pp. 149–179.
D. Mandallaz and J. Mau. Comparison of different methods for decision-making in bio-equivalence assessment.Biometrics 37:213–222 (1981).