Role of physiologically based biopharmaceutics modeling (PBBM) in fed bioequivalence study waivers: regulatory outlook, case studies and future perspectives
S Kollipara, FS Martins, M Sanghavi… - Journal of …, 2024 - 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 …
Predicting transporter mediated drug–drug interactions via static and dynamic physiologically based pharmacokinetic modeling: A comprehensive insight on where …
G Vijaywargi, S Kollipara, T Ahmed… - … & Drug Disposition, 2023 - Wiley Online Library
The greater utilization and acceptance of physiologically‐based pharmacokinetic (PBPK)
modeling to evaluate the potential metabolic drug–drug interactions is evident by the …
modeling to evaluate the potential metabolic drug–drug interactions is evident by the …
A new version of the tissue composition-based model for improving the mechanism-based prediction of volume of distribution at steady-state for neutral drugs
P Poulin, JM Nicolas, F Bouzom - Journal of Pharmaceutical Sciences, 2024 - Elsevier
In-vitro models are available in the literature for predicting the volume of distribution at
steady-state (Vd ss) of drugs. The mechanistic model refers to the tissue composition-based …
steady-state (Vd ss) of drugs. The mechanistic model refers to the tissue composition-based …