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Bioequivalence of two drugs is usually demonstrated by rejecting two one‐sided null hypotheses using the two one‐sided tests for pharmacokinetic parameters: area under the concentration‐time curve (AUC) and maximum concentration (Cmax). By virtue of the intersection–union test, there is no need for multiplicity adjustment in testing the two one‐sided null hypotheses within each parameter. However,...
The topic of applying two‐stage designs in the field of bioequivalence studies has recently gained attention in the literature and in regulatory guidelines. While there exists some methodological research on the application of group sequential designs in bioequivalence studies, implementation of adaptive approaches has focused up to now on superiority and non‐inferiority trials. Especially, no comparison...
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