Role of Physiologically Based Biopharmaceutics Modeling (PBBM) in Fed Bioequivalence Study Waivers: Regulatory Outlook, Case Studies and Future Perspectives

Autor: Kollipara, Sivacharan, Martins, Frederico S., Sanghavi, Maitri, Santos, Gustavo Mendes Lima, Saini, Anuj, Ahmed, Tausif
Zdroj: In Journal of Pharmaceutical Sciences February 2024 113(2):345-358
Databáze: ScienceDirect