Derisking Formulation Strategies Using PBBM: Mechanistic Case Studies on Evaluating Food Effects and Guiding Dissolution Specifications

Authors: Mudie D
Conference: AAPS
Keywords: AAPS 2025, dissolution, Food effects, gastroplus, pbbm, PBPK
Software: GastroPlus®

Session 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.

By Deanna Mudie

American Association of Pharmaceutical Scientists (AAPS) PharmSci360, November 9-12, 2018, San Antonio, TX