PBPK Workshop 2026

Children, pregnant and breastfeeding women are underserved for pharmacotherapy. Because drug dosing information in these populations is often insufficient or scarce, physiologically-based pharmacokinetic (PBPK) models of medicines verified using data collected throughout drug development and clinical studies, coupled with virtual physiology models representing specific populations offer an attractive solution to support dosing decisions. Today, PBPK is routinely used in drug development and registration to address questions on drug-drug interactions and oral absorption. The use of PBPK in organ impairment and paediatric drug dosing is emerging. However, the application of PBPK to address dosing questions in children, pregnant and lactating women has not been widely recognized.

A major roadblock to the use of PBPK is the perceptions of the complexity of the approach that require special modelling expertise, and the lack of understanding of the state-of-the-technology of PBPK by many healthcare providers who are in need of optimal dosing in real-life situations. The workshop intends to fill the translational gap between the modelling and simulation community and decision makers at the forefront of global drug development and clinical care.

Objectives

Understand basics of PBPK modelling, its utility and impact in drug development, and key considerations when applying these models to evaluate drug dosing in children, pregnant and breastfeeding women
Use PBPK models, through hands-on simulations to evaluate the impact of physiological changes on a drug’s disposition, and the implication of dose modification in these populations
Discuss the necessary framework for implementation of simulation-based evidence, along with other information, to inform optimal drug use
Understand regulatory considerations of PBPK
Discuss the necessary framework for implementation of simulation-based evidence, along with other information, to inform optimal drug use
Understand regulatory considerations of PBPK