Model-informed Drug Development and Precision Dosing in Neonates and Infants

Neonates and infants undergo rapid developmental changes. In conjunction with limited pharmacokinetic data, the selection of an appropriate individual drug dose remains a challenge.

In this collaborative project with the German Federal Institute for Drugs and Medical Devices (BfArM), we apply model-informed approaches to identify the requirements for accurate estimation of individual pharmacokinetic parameters to guide tailored dosing in neonates and infants. The aim of our project is to derive recommendations for the design of optimal sampling schedules in pharmacokinetic studies, taking into account ontogenetic and age-related factors.