Purpose

In the realm of pharmaceutical R&D, the quest for enhanced predictive accuracy and efficiency for Fed State PBPK models has never been more pressing. this work seeks to revolutionize the current state-of-the-art by accounting for the influence of meal calories and fat content on critical physiological processes—gastric emptying and intestinal bile concentrations. The implications of this research offer the promise of refined clinical data predictions, especially pertinent to BCS class II molecules. By deciphering how drug formulations interact with meals of varying composition, such as a low calorie/fat versus high calorie/fat FDA breakfast, we aim to unravel valuable insights that can inform drug labeling, reduce food effect studies, and expedite formulation development. We will review the high-level results of this new model on prediction of a multitude of compounds in the fed stat

By James Mathew Mullin

AAPS 2023 PharmSci 360,Orlando, FL, October 22-25, 2023