Evaluation of model-integrated evidence approaches for pharmacokinetic bioequivalence studies using model averaging methods.

ABSTRACT: Conventional approaches for establishing bioequivalence (BE) between test and reference formulations using non-compartmental analysis (NCA) may demonstrate low power in pharmacokinetic (PK) studies with sparse sampling. In this case, model-integrated evidence (MIE) approaches for BE assessment have been shown to increase power, but may suffer from selection bias problems if models are built on the same data used for BE assessment. This work presents model averaging methods for BE evaluation and compares the power and type I error of these methods to conventional BE approaches for simulated studies of oral and ophthalmic formulations. Two model averaging methods were examined: bootstrap model selection and weight-based model averaging with parameter uncertainty from three different sources,

SUBMITTER: Bjugard Nyberg H 

PROVIDER: S-EPMC11494900 | biostudies-literature | 2024 Oct

REPOSITORIES: biostudies-literature