1996BiometrikaRequires access

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

Dieter Hauschke

Open publisher page 9 citations

Abstract

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.

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What this paper is about

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.

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OpenAlex reports 9 citations for this work. Citation counts describe recorded attention and do not establish research quality.

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Available abstract

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 concepts: Bioequivalence, Mathematics, Crossover study, Statistics, Econometrics, Medicine, Pharmacology, Pharmacokinetics

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