Role of Physiologically Based Biopharmaceutics Modeling (PBBM) in Fed Bioequivalence Study Waivers: Regulatory Outlook, Case Studies and Future Perspectives
S Kollipara, F Martins, M Sanghavi, GML Santos… - Journal of …, 2023 - Elsevier
Over the past few decades, physiologically based biopharmaceutics modeling (PBBM) has
demonstrated its utility in both new drug and generic product development. Applications of …
demonstrated its utility in both new drug and generic product development. Applications of …