We propose a Pediatric Pharmacology Research Unit (PPRU) at University of Texas Southwestern Medical Center (UTSWMC) and Children's Medical Center of Dallas (CMC) in response to the RFA-HD-03-D01. We have more than 35 years of experience in designing and conducting clinical trials in newborns, infants and older children. CMC is a 350 bed, major pediatric primary and tertiary care facility in North Texas with a diverse patient population, and with one of the busiest pediatric emergency rooms and intensive care units in the country. Its newborn nursery located within the adjacent Parkland Memorial Hospital is one of the largest in the county, with over 16,000 live births annually. It is equiped with in-patient and out-patient monitoring units. The CMC pharmacy has participated in more than 500 research studies and has full time research pharmacists. We have access to an analytical laboratory that specializes in developing and validating new assays for drug monitoring. We have one of the oldest and largest pediatric infectious disease fellowship training programs in the US and also participate in training PharmD residents. Because of these extensive resources and experienced support services, a PPRU at Dallas will help advance the overall pediatric pharmacologic research including pharmacokinetics, pharmacodynamics, safety and efficacy studies. The specific of the unit are the following: 1- To be a PPRU center to conduct pharmcokinetics, drug-bioalvailability, formulation, safety, tolerability and efficiacy trials in pediatrics 2- To gather data for age-specific labeling of drugs in pediatrics 3- To conduct research in novel areas of pediatric pharmacology 4- To apply pharmacogenoflhics to better understand and treat diseases of infants and children 5- To develop and apply proteomics for pathogenesis and pediatric pharmacology studies 6- To develop the PPRU as a resource for teaching and training pharmacy students, PharmD residents and fellows, pediatric sub-specialty fellows., and the Associate Pediatric Pharmacologist We will actively collaborate with the network by providing protocols that could be conducted by centers in the network and by participating in trials brought forward by other units.
