Senior Scientific Advisor Certara UK SHEFFIELD, United Kingdom
Physiologically Based Pharmacokinetic (PBPK) models can be used to virtually assess the formulation's 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, optimising 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 of dermal products.
Upon completion, participant will get familiar with various dermal case studies applying PBPK models for VBE assessments.
Upon completion, participant will get familiar with regulatory requirements when using PBPK models in VBE studies for dermal products.
