Abstract Background and Objective More than half of all drugs are still prescribed off-label to
children. Pharmacokinetic (PK) data are needed to support off-label dosing, however for …

Abstract Development and guidance of dosing schemes in children have been supported by
physiology‐based pharmacokinetic (PBPK) modeling for many years. PBPK models are built …

Physiologically based pharmacokinetic (PBPK) modeling can be an attractive tool to
increase the evidence base of pediatric drug dosing recommendations by making optimal …

There has been a significant increase in the use of physiologically based pharmacokinetic
(PBPK) models during the past 20 years, especially for pediatrics. The aim of this study was …

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 …

Physiologically based pharmacokinetic (PBPK) models offer a mechanistic understanding of
the disposition of the drug in the body. When well informed and conducted, this may lead to …

Interest in determining safe and efficacious doses for drug administration in pediatric
patients has increased dramatically in recent years. However, published pediatric clinical …

Abstract Purpose of Review This article provides a brief overview of the development of
pediatric physiologically based pharmacokinetic (PPBPK) models, the challenges of …

The pharmacokinetics (PKs) and safety of medications in particular groups can be predicted
using the physiologically‐based pharmacokinetic (PBPK) model. Using the PBPK model …

Pediatric physiologically‐based pharmacokinetic (PBPK) models have broad application in
the drug development process and are being used not only to project doses for clinical trials …