This proposal is in response to RFA number HD-98-002 to establish a Pediatric and Newborn Center for Clinical Pharmacology at Wayne State University School of Medicine and the Children's Hospital of Michigan. The Center will perform clinical studies on drugs in newborn babies, infants and children, in collaboration with other Network Centers from which requisite data on drugs and the neonatal and pediatric population will be generated to support FDA-approved labeling of drugs for the increasing numbers of drugs being prescribed and used in these populations. Due to the lack of data, the majority of these drugs are not labeled and approved for newborns and children. The long term goal is to have all drugs be labeled and approved for use in babies and children.
The specific aims are: 1) to develop a neonatal clinical drug trials component of the Pediatric Pharmacology Research Units (PPRU) Network, focusing on drug evaluation in the preterm and term newborns including studies on pharmacodynamics, bioavailability, formulations, kinetics, safety and efficacy of new molecules and old drugs currently used in these babies; 2) To integrate a multinational neonatal clinical Drug Trials group to enhance the capability of the PPRU to conduct drug studies with the least time on a large neonatal population. 3) To collaborate with other PPRU network units and NICHD staff to identify drugs to be studied in newborns and children and to develop protocols and perform these studies; 4) To contract and collaborate with various pharmaceutical companies to sponsor and to perform requisite drug trials in newborns and children leading to labeling of the sponsor's drugs; 5) to foster drug research by various pediatric subspecialties thru provision of assistance in protocol development, study performance and the infrastructure to conduct these drug studies and 6) to create and provide an innovative, stimulating, productive and rigorous environment for the education and training of clinical pharmacology fellows, residents, pharmacists and other health care givers to attain expertise in neonatal and pediatric pharmacology. With a large newborn and pediatric patient population, an established clinical pharmacology program and laboratories, tradition, commitment and expertise on drug studies in newborns and children, and a strong team of pharmacists, pharmacologists, neonatologists, intensivists and other subspecialties, the Center can lead, participate and substantially contribute to many drug studies in various therapeutic categories.
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