In this article, the sample size calculations pertaining to a therapeutic equivalence trial based on a confidence interval are described for both normally and dichotomously distributed data. Other issues regarding equivalence trials are also discussed.
DunnettCWGentM.Significance testing to establish equivalence between treatments with special reference to data in the form of 2 × 2 tables. Biometrics.1977;33:593–602.
2.
BlackwelderWC.Proving the null hypothesis in clinical trials —a review. Contr Clin Trials.1982;3:345–354.
3.
MakuchASimonR.Sample size requirements for evaluating a conservative therapy. Cancer Treat Rept.1978;7:1037–1040.
4.
DurrlemanSSimonR.Planning and monitoring of equivalence studies. Biometrics.1990;46:329–336.
5.
WestlakeWJ.Bioavailability and bioequivalence of pharmaceutical formulations. In: PeaceKE ed. Biopharmaceutical statistics for drug development.New York: Marcel Dekker, Inc.; 1988:329–352.
6.
European Pharmacopoeia.Vols I and II. 1969, 1971. Paris, France.
7.
KirkwoodTB.Bioequivalence testing—a need to rethink. Biometrics.1981;37:589–591.
8.
FinneyDJ.Statistical method in biological assay. 2nd ed, Chap 2. New York: Hafner Publishing Company; 1961.
9.
YeeKF.The calculation of probabilities in rejecting bioequivalence. Biometrics.1986;42:961–965.