The concept of “Virtual Bioequivalence” (V-BE) is built on the back of combination physiologically-based (PBPK) modelling, integration of results from in vitro tests on drug product, use of pre-existing data on systems and drug. The subject is growing out of its infancy as multiple applications are now reported in the literature. Passing the BE criteria involves showing similarity in systemic exposure (pharmacokinetic profile - PK) following the administration of the test and reference products. However, indicating equivalence for average profile is not adequate and the degree of population variability around the average, by means of 90% confidence interval (CI), needs to be within certain range of the reference product (typically 80-125%). The presentation aims to demonstrate the differences between various strategies that help to capture the CI around the PK profile during conduct of VBE studies. The study highlights the propagating physiological within-subject variability (WSV) to PK profiles and how these might be different for test and reference products.
Learning Objectives:
Upon completion, participants:
- Should have a good idea of the VBE studies and use of PBPK models for this purpose
Upon completion, participants:
- Distinguish between different strategies of incorporating variability into VBE studies
Upon completion, participants:
- Enlist the physiological parameters of the GI-tract where measures of WSV are known
Upon completion, participants:
- Understand how observed WSV of PK parameters can be used to infer WSV of GI tract
Upon completion, participants:
- Be able to critically analyse the VBE studies which are not conducted with best practice
