Senior Principal Scientist Simulations Plus, Inc. Bend, Oregon
Physiologically based biopharmaceutics modeling (PBBM) is an increasingly valuable tool in drug development, enabling the prediction of in vivo performance based on in vitro data, drug properties, and physiological conditions. This presentation highlights two recent case studies that demonstrate the utility of PBBM in evaluating food effects and guiding dissolution specification development.
In both cases, PBBM was used to investigate how gastrointestinal conditions—particularly fed versus fasted states—impact drug absorption and systemic exposure. The models integrated dissolution, precipitation, metabolism, and GI transit to mechanistically explain clinically observed differences under various dosing conditions. These insights supported the development of clinically relevant dissolution methods and helped define safe formulation boundaries without the need for additional in vivo studies.
Together, these examples illustrate how PBBM can inform formulation design, de-risk development decisions, and reduce reliance on clinical trials by enabling virtual assessments. By bridging in vitro and in vivo understanding, PBBM strengthens confidence in product performance and supports science-based regulatory strategies.
Learning Objectives:
Understand how PBBM mechanistically integrates formulation dependent processes—such as dissolution, precipitation, gastrointestinal transit, and metabolism—to simulate oral drug absorption under varying prandial conditions.
See how PBBM can support development of clinically relevant dissolution specifications, elucidate food effect mechanisms, and inform risk assessment across formulation types using salt and amorphous drug forms as examples.
Explore how PBBM can guide the selection and optimization of formulation parameters, establish safe and effective dissolution boundaries, and minimize the need for additional in vivo studies during late-stage development.
