Physiologically Based Pharmacokinetic (PBPK) models can be used to virtually assess formulations bioequivalence (VBE). These applications cover a wide range of oral, dermal, inhalation as well as long acting injectable formulations. Such capabilities present opportunities and challenges in informing, optimizing and saving many unnecessary BE studies. In addition it allows expanding BE studies beyond healthy populations within a patient-centric paradigm. To enable PBPK modeling for regulatory decision making, models should be sufficiently qualified and verified for the intended purpose. In this session the state of the arts in using PBPK models for VBE studies, requirements, and case studies are presented.
Learning Objectives:
Upon completion, participant will get familiar with requirements and best practices when applying PBPK for VBE assessment.
Upon completion, participant will get familiar with various case studies applying PBPK models for VBE assessments.
Upon completion, participant will get familiar with regulatory requirements when using PBPK models in VBE studies.
