Adaptive designs for bioequivalence trails

In recent years, there has been a growing interest within the medical research community in the application of adaptive designs in drug development. One potential application of adaptive designs is for bioequivalence trials, as they provide a means for managing the uncertainty around the anticipated...

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Bibliographic Details
Main Author: Montague, Timothy H.
Published: University of Reading 2007
Subjects:
Online Access:http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.494779
Description
Summary:In recent years, there has been a growing interest within the medical research community in the application of adaptive designs in drug development. One potential application of adaptive designs is for bioequivalence trials, as they provide a means for managing the uncertainty around the anticipated variance to be used to power the study. If the anticipated variance is less than the true variance, the study may be under-powered resulting in the inability to demonstrate bioequivalence. Adaptive designs which allow one to both stop for success or futility at the interim or re-estimate the sample size if the study continues are explored in this thesis.