A Novel Approach to Justify Dissolution Differences in an Extended-Release Drug Product using Physiologically Based Biopharmaceutics Modeling and Simulation

27 September 2022 12:15 - 12:50

In this work, a novel approach to establish in vivo similarity between higher and lower strength formulations without doing a BE study is presented. Physiologically Based Biopharmaceutics Model (PBBM) based approaches are also being encouraged by regulators with an effort to reduce unnecessary use of healthy human subjects for generic BE studies.