An Open-Source Framework for Virtual Bioequivalence Modeling and Clinical Trial Design.

ABSTRACT: To establish bioequivalence (BE) of a generic test formulation with respect to a reference listed drug, it is necessary to demonstrate a comparable rate and extent to which active ingredients reach the site of action. To decrease unnecessary human testing and simulate scenarios involving specific populations or challenges with recruitment or study design, industry and regulators are increasingly considering in silico virtual bioequivalence (VBE) approaches. This tutorial introduces the VBEToolbox R package: a toolbox within the Open Systems Pharmacology framework to streamline and standardize computational VBE workflows. The package integrates in vitro and in vivo data to train pharmacokinetic models through inference of inter-individual variability from clinical data and establishment of

SUBMITTER: Hamadeh A 

PROVIDER: S-EPMC12706426 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature