Under the direction of Alexander Vinks, PharmD, PhD, the Pediatric Pharmacology Research Unit (PPRU) is one of just 13 units across the United States established by the National Institute of Child Health and Human Development in response to the need for appropriate drug therapy for pediatric patients (www.ppru.org). Its mission is to conduct Phase I - IV clinical pharmacology trials that conform to GCP/ICH regulatory requirements in a safe, effective and timely fashion to produce data that enables expanded labeling of drugs for pediatric patients. The PPRU staff at Cincinnati Children's is particularly interested in pharmacogenetics (PG), population pharmacokinetic (PK)-pharmacodynamic (PD) modeling, and has extensive expertise in clinical trial design and simulation. Our unit is the lead site for five studies ranging from specific drug class evaluations (e.g. antiepileptic drugs in the Childhood Absence Study with Neurology), pharmacogenetics (e.g. mycophenolic acid in transplant patients with Nephrology), and pharmacokinetics, safety and efficacy studies (e.g. lorazepam sedation with Critical Care).
