Predicting Drug Exposure over the Entire Pediatric Age Range

Physiologically-based pharmacokinetic (PBPK) modeling and simulation using Simcyp Pediatric is increasingly being used to accelerate drug development and inform clinical dosing decisions in children.

Cautiousness surrounding the routine adoption of pediatric PBPK modeling and simulation is being overcome by the growing appreciation that this approach is not intended as a complete substitute for clinical investigation, but instead is an essential tool to maximize the value of prior information as part of a “learn-and-confirm” strategy. Increasingly, validation studies are being published highlighting the power of PBPK and its applications in drug development, as well as guiding best practice.

Researchers at the University of Florida, working with colleagues at The Children’s Hospital of Philadelphia and the US FDA, set out to mechanistically understand APAP metabolism in children and provide a framework for the development and validation of pediatric PBPK models.

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