Demystifying physiologically based pharmacokinetic modelling among non-modelers towards model-informed medicine use in under-served populations. [version 1; peer review: 3 approved, 2 approved with reservations]

Abstract

Physiologically based pharmacokinetic (PBPK) models represent computational technology to characterize drug behavior within the context of detailed human physiology. Today, PBPK is routinely used in drug development and regulatory approval to support decisions on how a medicine can be used under certain clinical conditions. As such, PBPK has the potential to enhance medicine use for populations that are often under-served globally in drug development and clinical care, namely pediatric patients, pregnant and lactating women. To facilitate broader applications of PBPK for these populations, we joined force and organized five hands-on workshops primarily to non-modelers on the principles of PBPK and its potential applications in pediatric and obstetric pharmacology in 2021 and 2022. In this open letter, we report learning objectives and content of such workshops and to highlight the significant value of these educational efforts.

Keywords

• Dosing
• Under-served Populations
• Model-informed Drug Development
• Pediatrics
• Pharmacokinetics
• Pregnancy
• eng