Alternative Analysis Approaches for the Assessment of Pilot Bioavailability/Bioequivalence Studies.

ABSTRACT: Pilot bioavailability/bioequivalence (BA/BE) studies are usually conducted and analysed similarly to pivotal studies. Their analysis and interpretation of results usually rely on the application of the average bioequivalence approach. However, due to the small study size, pilot studies are inarguably more sensitive to variability. The aim of this work is to propose alternative approaches to the average bioequivalence methodology, in a way to overcome and reduce the uncertainty on the conclusions of these studies and on the potential of test formulations. Several scenarios of pilot BA/BE crossover studies were simulated through population pharmacokinetic modelling. Each simulated BA/BE trial was analysed using the average bioequivalence approach. As alternative analyses, the centrality of t

SUBMITTER: Henriques SC 

PROVIDER: S-EPMC10222359 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature