Best Practices in the Development and Validation of Physiologically Based Biopharmaceutics Modeling. A Workshop Summary Report

This workshop report summarizes the proceedings of Day 2 a three-day on “Current State and Future Expectations Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes Controls”. From drug product quality perspective, physiologically based biopharmaceutics modeling (PBBM) is tool link variations in attributes vivo outcomes enabling establishment clinically relevant specifications (CRDPS). focused best practices developing, verifying validating PBBM. manuscript gives an overview podium presentations breakout (BO) session discussions related (1) challenges opportunities for using PBBM assess clinical impact formulation manufacturing changes performance product, (2) account parameter uncertainty variability during model development, (3) verification validation (4) knowledge gaps leveraging virtual bioequivalence simulations.