Mechanistic PK/PD Modeling in Pediatrics
Dr. Toufigh Gordi, Rosa and Co.; President, PK/PD and Clinical Pharmacology Services
Drug development for pediatric patients can be difficult due to these subjects being a limited, fragile population with high safety requirements. Microdosing and Accelerator Mass Spectrometry (AMS) could be an alternative methodology for neonatal PK studies. AMS-derived PK and system pharmacology models for ursodiol, a secondary bile acid, were developed for use with neonates. We investigated the utility of each model as well as investigating possible causes of the observed variability.