Related Experiment Video
Updated: Oct 27, 2025

Author Spotlight: Developing a Simple and Robust Hepatic Model for Pharmacological and Toxicological Applications
Published on: October 20, 2023
A best practice framework for applying physiologically-based pharmacokinetic modeling to pediatric drug development
Trevor N Johnson1, Ben G Small1, Eva Gil Berglund2
1Certara UK Limited Simcyp Division, Sheffield, UK.
Abstract:
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 but increasingly to replace clinical studies. However, the approach has yet to become fully integrated in regulatory submissions. Emerging data support an expanded integration of the PBPK model informed approach in regulatory guidance on pediatrics. Best practice standards are presented for further development through interaction among regulators, industry, and model providers.
Related Concept Videos
Pharmacokinetic Models: Comparison and Selection Criterion
Physiological models take a detailed approach by considering specific molecular processes. They can predict drug distribution, metabolism, and elimination changes, providing a comprehensive understanding of how drugs interact with the body.
Pharmacokinetic Models: Overview
There are three primary types of models: empirical, compartment, and physiological. Empirical models, with minimal...
Model Approaches for Pharmacokinetic Data: Distributed Parameter Models
The distributed parameter models are specifically designed to account for variations and differences in some drug classes. This model is particularly useful for assessing regional concentrations of anticancer or...
Pharmacokinetics in Pediatric Patients: Drug Distribution
Model Approaches for Pharmacokinetic Data: Physiological Models
Pharmacokinetics in Pediatric Patients: Drug Metabolism

