The North Carolina Collaborative Pediatric Pharmacology Research Unit (NCC-PPRU) will be composed of personnel from Duke University and the University Of North Carolina (UNC). The NCC-PPRU will help develop new medications with pediatric indications and increase the availability of pediatric pharmacokinetic data. Faculty leadership will ensure the integration of the infrastructure of the 2 institutions. The NCC-PPRU program will have 6 specific aims: 1) To conduct studies in bioavailability, metabolism pharmacokinetics, pharmacodynamics, and the safety and efficacy of new and licensed drugs. These studies, led by Dr. Pollack (UNC), will rely on the infrastructure of the UNC School of Pharmacy Quantitative Chromatography and PKIPD Laboratories. 2) To form partnerships with industry and gather the necessary clinical data to support FDA approval of pediatric indications for new and previously licensed medications. The accrual of patients into collaborative studies developed by the PPRU Network will be led by Dr. McKinney (Duke) and will grow from a mature interdisciplinary clinical trials group at Duke University-the Pediatric Clinical Research Program. Dr. McKinney, assisted by Drs. Benjamin (Duke) and Retsch-Bogart (UNC), will integrate the clinical departments of both institutions. Drs. Schulman (Duke) and Retsch-Bogart will lead the effort to coordinate the General Clinic Research Centers' resources. Drs. Benjamin and Li (Duke) will integrate the coordinating center resources within the Duke Clinical Research institute. 3) To develop novel approaches and innovative technique in pediatric pharmacology. Dr. Pollack will lead these efforts; Dr. Walson (Senior Consultant, Cincinnati) will facilitate a partnership with the Center for Education and Research in Therapeutics to achieve this aim. 4) To conduct studies on the developmental characteristics of drug-metabolizing enzymes, transporters, and receptors. Dr. LeCluyse (UNC) will lead these efforts in the Drug Metabolism/Transport Laboratory. 5) To apply pharmacogenomic and proteomic tools in pediatric clinical studies. Dr. Mangum (Duke) will lead this collaborative effort in conjunction with the genomics institutes of Duke and IJNC. 6) To train physicians and pharmacologists in clinical and developmental pharmacology: the centerpiece will be a 3-year pediatric pharmacology fellowship. Drs. Brouwer and Lindley (UNC) will lead this program.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10HD045962-02
Application #
6868937
Study Section
Special Emphasis Panel (ZHD1-DSR-A (01))
Program Officer
Giacoia, George
Project Start
2004-03-08
Project End
2008-12-31
Budget Start
2005-01-01
Budget End
2005-12-31
Support Year
2
Fiscal Year
2005
Total Cost
$362,204
Indirect Cost
Name
Duke University
Department
Pediatrics
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Xiong, Xuejian; Bales, Elise S; Ir, Diana et al. (2017) Perilipin-2 modulates dietary fat-induced microbial global gene expression profiles in the mouse intestine. Microbiome 5:117
Sampson, Mr; Cohen-Wolkowiez, M; Benjamin Jr, Dk et al. (2013) Pharmacokinetics of Antimicrobials in Obese Children. GaBI J 2:76-81
Bauserman, Melissa S; Laughon, Matthew M; Hornik, Christoph P et al. (2013) Group B Streptococcus and Escherichia coli infections in the intensive care nursery in the era of intrapartum antibiotic prophylaxis. Pediatr Infect Dis J 32:208-12
Watt, Kevin; Manzoni, Paolo; Cohen-Wolkowiez, Michael et al. (2013) Triazole use in the nursery: fluconazole, voriconazole, posaconazole, and ravuconazole. Curr Drug Metab 14:193-202
Hornik, Christoph P; Herring, Amy H; Benjamin Jr, Daniel K et al. (2013) Adverse events associated with meropenem versus imipenem/cilastatin therapy in a large retrospective cohort of hospitalized infants. Pediatr Infect Dis J 32:748-53
Benjamin Jr, Daniel K; Deville, Jaime G; Azie, Nkechi et al. (2013) Safety and pharmacokinetic profiles of repeated-dose micafungin in children and adolescents treated for invasive candidiasis. Pediatr Infect Dis J 32:e419-25
Wynn, James L; Hansen, Nellie I; Das, Abhik et al. (2013) Early sepsis does not increase the risk of late sepsis in very low birth weight neonates. J Pediatr 162:942-8.e1-3
Lee, Jan Hau; Hornik, Christoph P; Benjamin Jr, Daniel K et al. (2013) Risk factors for invasive candidiasis in infants >1500 g birth weight. Pediatr Infect Dis J 32:222-6
Downey, L C; Benjamin Jr, D K; Clark, R H et al. (2013) Urinary tract infection concordance with positive blood and cerebrospinal fluid cultures in the neonatal intensive care unit. J Perinatol 33:302-6
Ericson, Jessica; Manzoni, Paolo; Benjamin Jr, Daniel K (2013) Old and new: appropriate dosing for neonatal antifungal drugs in the nursery. Early Hum Dev 89 Suppl 1:S25-7

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