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