A best practice framework for applying physiologically-based pharmacokinetic modeling to pediatric drug development

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.

Automated summary

Pediatric physiologically-based pharmacokinetic (PBPK) models have broad applications in drug development, being used to project doses and replace clinical studies. Despite this, full integration of PBPK models in regulatory submissions is still lacking. Emerging data supports the expanded integration of PBPK models in pediatric regulatory guidance, presenting best practice standards for further development through interaction among regulators, industry, and model providers.