Development and Verification of a Japanese Pediatric Physiologically Based Pharmacokinetic Model with Emphasis on Drugs Eliminated by Cytochrome P450 or …

TN Johnson, K Abduljalil, X Pan… - The Journal of Clinical …, 2023 - Wiley Online Library
Physiologically based pharmacokinetic (PBPK) models are useful in bridging drug exposure
in different ethnic groups, and there is increasing regulatory application of this approach in …

Predictive performance of physiologically based pharmacokinetic (PBPK) modeling of drugs extensively metabolized by major cytochrome P450s in children

W Zhou, TN Johnson, KH Bui… - Clinical …, 2018 - Wiley Online Library
The accuracy of physiologically based pharmacokinetic (PBPK) model prediction in children,
especially those younger than 2 years old, has not been systematically evaluated. The aim …

Meta‐analysis of hepatic cytochrome P450 ontogeny to underwrite the prediction of pediatric pharmacokinetics using physiologically based pharmacokinetic modeling

VV Upreti, JL Wahlstrom - The Journal of Clinical …, 2016 - Wiley Online Library
The accurate prediction of pharmacokinetics (PK) is fundamental to underwriting safety and
efficacy in pediatric clinical trials; age‐dependent PK may be observed with pediatrics …

Another step toward qualification of pediatric physiologically based pharmacokinetic models to facilitate inclusivity and diversity in pediatric clinical studies

BG Small, TN Johnson… - Clinical Pharmacology & …, 2023 - Wiley Online Library
Robust prediction of pharmacokinetics (PKs) in pediatric subjects of diverse ages,
ethnicities, and morbidities is critical. Qualification of pediatric physiologically‐based …

Regulatory experience with physiologically based pharmacokinetic modeling for pediatric drug trials

R Leong, MLT Vieira, P Zhao… - Clinical …, 2012 - Wiley Online Library
Physiologically based pharmacokinetic (PBPK) approaches that incorporate the
developmental physiology and ontogeny of cytochrome P450 (CYP) enzymes may have …

European regulatory perspective on pediatric physiologically based pharmacokinetic models

S Cole, JL Hay, E Luzon, A Nordmark… - International journal of …, 2017 - Future Science
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 …

Development of a virtual Chinese pediatric population physiological model targeting specific metabolism and kidney elimination pathways

X Yao, X Liu, S Tu, X Li, Z Lei, Z Hou, Z Yu… - Frontiers in …, 2021 - frontiersin.org
Background: Physiologically based pharmacokinetic (PBPK) modeling and simulating may
be a powerful tool in predicting drug behaviors in specific populations. It is a mathematical …

Prediction of Pediatric Pharmacokinetics for CYP3A4 Metabolized Drugs: Comparison of the Performance of Two Hepatic Ontogeny Within a Physiologically Based …

M Codaccioni, RL Southall, J Dinh… - The Journal of Clinical …, 2024 - Wiley Online Library
The rapid growth in the use of pediatric physiologically based pharmacokinetic (PBPK)
models, particularly for regulatory applications, has focused emphasis on model verification …

Model qualification of the PK-Sim® pediatric module for pediatric exposure assessment of CYP450 metabolized compounds

YE Yun, AN Edginton - Journal of Toxicology and Environmental …, 2019 - Taylor & Francis
Pediatric physiologically based pharmacokinetic (PBPK) models facilitate the estimation of
pharmacokinetic (PK) parameters in children under specific exposure conditions. In human …

Predicting Pediatric Drug Disposition-Present and Future Directions of Pediatric Physiologically-Based Pharmacokinetics.

SJ Miyagi, JR Long-Boyle - Drug Metabolism Letters, 2015 - europepmc.org
This mini-review examines the current state of pediatric physiologically-based
pharmacokinetic (PBPK) modeling, including methodologies, approaches, and recent …