Exact Properties of Some Heteroscedastic TOST Alternatives for Bioequivalence

Gwowen Shieh, Show-Li Jan & Cheng-Shiun Leu
The two one-sided tests (TOST) procedure is the common method for assessing bioequivalence between two different drugs or formulations of the same drug. Several solutions to Behrens-Fisher problem have been extended to establish statistical equivalence under variance heterogeneity. Unlike other existing studies that rely exclusively on simulation results, the analytical formulas of power and Type I error rate are derived. Exact numerical investigations were conducted to evaluate the behavior of the Welch–Satterthwaite, Cochran–Cox, and Banerjee–McCullough...
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