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

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

Journal of Pharmaceutical Sciences

Fecha de publicación: 12 de octubre de 2020

DOI: https://doi.org/10.1016/j.xphs.2020.09.058

Autores: Neil Parrott, Sandra Suarez-Sharp, Filippos Kesisoglou, Shriram M. Pathak, David Good, Christian Wagner, André Dallmann, James Mullin, Nikunjkumar Patel, Arian Emami Riedmaier, Amitava Mitra, Kimberly Raines, James Butler, Maziar Kakhi, Min Li, Yang Zhao, Eleftheria Tsakalozou, Talia Flanagan, Jennifer Dressman, Xavier Pepin

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

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