This proposal is in response to RFA #HD-93-06 to establish a Children's Center for Clinical Pharmacology Studies at Wayne State University School of Medicine, Children's Hospital of Michigan, as on e the sites within the Network of Pediatric Pharmacology Research Units. The Unit will conduct clinical trials of drugs in infants and children, collaboration with other Network Units, from which data will be generated to support FDA-approved labeling for an increased number of drugs which are prescribed for children. The ultimate goal is to have all drugs which are prescribed for children, eventually studied and labeled for use by pediatric patients.
Specific aims i nclude: 1) To collaborate with other Network Units and NICHD staff to conduct pediatric clinical trials of drugs which have established or anticipated use in children but which are not labeled for use in pediatric patients; 2) To contract with pharmaceutical sponsors to conduct clinical trials in children which will lead to FDA approval and labeling of the sponsor's drug for pediatric use; 3) To develop and conduct investigator-initiated studies of a more basic nature which will focus on the influence of growth and maturation on the metabolism, pharmacodynamics, and pharmacokinetics of drugs; 4) To provide a rigorous educational and training environment in which fellow and fully trained pediatricians can attain expertise in pediatric clinical pharmacology. This application arises out of recognition that the majority of prescription drugs on the market in the U.S. today are not labeled for use by children even though most of them ar required to treat illness in children. Lack of labeling stems directly from lack of studies to support labeling as required by the FD&C statutes. As a member of the Network, the Unit at WSU, Children's Hospital of Michigan will participate in multicenter studies with the other Units in the Network. With an established clinical Pharmacology Division, large pediatric patient population, clinical pharmacology research laboratory, and representation from all pediatric subspecialities, the Unit will be a substantial contributor to clinical Pharmacology Division, large pediatric patients population, clinical pharmacology research laboratory, and representation from all pediatric subspecialities, the Unit will be a substantial contributor to clinical trials in a variety of therapeutic categories.
| Jones, Bridgette L; Kearns, Gregory; Neville, Kathleen A et al. (2013) Variability of histamine pharmacodynamic response in children with allergic rhinitis. J Clin Pharmacol 53:731-7 |
| Kearns, Gregory L; Leeder, J Steven; Gaedigk, Andrea (2010) Impact of the CYP2C19*17 allele on the pharmacokinetics of omeprazole and pantoprazole in children: evidence for a differential effect. Drug Metab Dispos 38:894-7 |
| Leeder, J Steven; Kearns, Gregory L; Spielberg, Stephen P et al. (2010) Understanding the relative roles of pharmacogenetics and ontogeny in pediatric drug development and regulatory science. J Clin Pharmacol 50:1377-87 |
| Blake, Michael J; Abdel-Rahman, Susan M; Pearce, Robin E et al. (2006) Effect of diet on the development of drug metabolism by cytochrome P-450 enzymes in healthy infants. Pediatr Res 60:717-23 |
| Pearce, Robin E; Leeder, J Steven; Kearns, Gregory L (2006) Biotransformation of fluticasone: in vitro characterization. Drug Metab Dispos 34:1035-40 |
| Capparelli, Edmund V; Reed, Michael D; Bradley, John S et al. (2005) Pharmacokinetics of gatifloxacin in infants and children. Antimicrob Agents Chemother 49:1106-12 |
| Blake, Michael J; Castro, Lisa; Leeder, J Steven et al. (2005) Ontogeny of drug metabolizing enzymes in the neonate. Semin Fetal Neonatal Med 10:123-38 |
| James, Laura P; Simpson, Pippa M; Farrar, Henry C et al. (2005) Cytokines and toxicity in acetaminophen overdose. J Clin Pharmacol 45:1165-71 |
| Kennedy, Mary Jayne; Jackson, Mary Anne; Kearns, Gregory L (2004) Delayed diagnosis of penicillin-resistant Streptococcus mitis endocarditis following single-dose amoxicillin prophylaxis in a child. Clin Pediatr (Phila) 43:773-6 |
| Kennedy, Mary Jayne; Abdel-Rahman, Susan M; Kashuba, Angela D M et al. (2004) Comparison of various urine collection intervals for caffeine and dextromethorphan phenotyping in children. J Clin Pharmacol 44:708-14 |
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