Abstract
It is well-accepted that off-label drug dosing recommendations for pediatric patients should be based on the best available evidence. However, the available traditional evidence is often low. To bridge this gap, physiologically-based pharmacokinetic (PBPK) modeling is a scientifically well-founded tool that can be used to enable model-informed dosing (MID) recommendations in children in clinical practice. In this tutorial, we provide a pragmatic, PBPK-based pediatric modeling workflow. For this approach to be successfully implemented in pediatric clinical practice, a thorough understanding of the model assumptions and limitations is required. More importantly, careful evaluation of an MID approach within the context of overall benefits and the potential risks is crucial. The tutorial is aimed to help modelers, researchers, and clinicians, to effectively use PBPK simulations to support pediatric drug dosing.
Original language | English |
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Pages (from-to) | 960-971 |
Number of pages | 12 |
Journal | Clinical Pharmacology and Therapeutics |
Volume | 114 |
Issue number | 5 |
Early online date | 8 Aug 2023 |
DOIs | |
Publication status | Published - Nov 2023 |
Bibliographical note
Funding Information:This publication is based on research funded by the Bill & Melinda Gates Foundation (INV‐001822). The findings and conclusions contained within are those of the authors and do not necessarily reflect positions or policies of the Bill & Melinda Gates Foundation.
Publisher Copyright:
© 2023 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.