A best practice framework for applying physiologically‐based pharmacokinetic modeling to pediatric drug development
Trevor N. Johnson, Ben G. Small, Eva Gil Berglund, Karen Rowland Yeo
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.
Topics & Concepts
Physiologically based pharmacokinetic modellingDrug developmentProcess (computing)Clinical PracticeBest practiceComputer scienceManagement scienceDrugClinical trialPharmacokineticsMedicinePharmacologyRisk analysis (engineering)EngineeringPolitical sciencePathologyFamily medicineOperating systemLawPharmaceutical studies and practicesPharmacogenetics and Drug MetabolismAntibiotics Pharmacokinetics and Efficacy