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Biometrika 1996 83(1):236-237; doi:10.1093/biomet/83.1.236
© 1996 by Biometrika Trust
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MISCELLANEA

A note on Welch's approximate t-solution to bioequivalence assessment

DIETER HAUSCHKE, VOLKER W. STEINIJANS and LUDWIG A. HOTHORN

Department of Biometry, Byk Gulden Pharmaceuticals Byk-Gulden-Straße 2, D-78467 Konstanz, Germany
Department of Bioinformatics, University of Hannover Herrenhäuser Straße 2, D-30419 Hannover, Germany

The crossover is considered to be the design of choice for bioequivalence studies and regulatory authorities currently require evidence of average bioequivalence which is a special case of population bioequivalence. To assess average bioequivalence, the double t-test can be performed without Welch's approximation.

Key Words: Bioequivalence • Double t-test • Heterogeneous variances • Welch's approximate t-solution


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