The Children's National Medical Center (CNMC) proposes to develop a Washington D.C. Pediatric Pharmacology Research Unit (W-PPRU) in collaboration with the Departments of Pediatrics of Georgetown University Medical Center and Howard University Hospital. The District of Columbia is a multiethnic, multiracial, and multicultural community with a broad socioeconomic base, ideally suited to perform clinical and translational pediatric research. This W-PPRU collaboration will bring complementary strengths and interests from the 3 institutions (i.e., broad patient base, minority recruitment of both subjects and trainees, translational and basic science programs). The PPRU will be housed within the NCRR funded Pediatric Clinical Research Center at CNMC in 3,000 sq. ft. of clinical space; it will have facilities for inpatient and outpatient studies. Although not currently a PPRU, CNMC has participated in 124 clinical trials that have enrolled 1494 children over the past 4 years. This has involved over 50 pediatric faculty in 12 subspecialties. The Principal Investigator, John van den Anker, M.D., Ph.D. is a neonatologistlclinical pharmacologist with prior experience as PI of a PPRU. The Unit will include a core laboratory that provides both mass spectrometry and molecular genetics resources and strong research pharmacy support. Additionally, there is a strong Data Management unit. The training mission will involve didactic courses, practicum experiences, and career development opportunities for a broad range of health care professionals. Proposed drug evaluation studies include pharmacokinetic/pharmacodynamic models for optimizing the treatment of neonatal pain (morphine), and the use of off-patent drugs (dopamine and dobutamine). Additional pharmacological studies will bring to the PPRLI Network new drugs used in Orphan Diseases (Duchenne Muscular Dystrophy and Urea Cycle Disorders) for which CNMC is an international Center.

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 #
5U10HD045993-02
Application #
6889557
Study Section
Special Emphasis Panel (ZHD1-DSR-A (01))
Program Officer
Giacoia, George
Project Start
2004-04-25
Project End
2008-12-31
Budget Start
2005-01-01
Budget End
2005-12-31
Support Year
2
Fiscal Year
2005
Total Cost
$375,000
Indirect Cost
Name
Children's Research Institute
Department
Type
DUNS #
143983562
City
Washington
State
DC
Country
United States
Zip Code
20010
Phelps, Dale L; Ward, Robert M; Williams, Rick L et al. (2013) Pharmacokinetics and safety of a single intravenous dose of myo-inositol in preterm infants of 23-29 wk. Pediatr Res 74:721-9
Rakhmanina, Natella Y; Neely, Michael N; Van Schaik, Ron H N et al. (2011) CYP3A5, ABCB1, and SLCO1B1 polymorphisms and pharmacokinetics and virologic outcome of lopinavir/ritonavir in HIV-infected children. Ther Drug Monit 33:417-24
Best, Brookie M; Capparelli, Edmund V; Diep, Huy et al. (2011) Pharmacokinetics of lopinavir/ritonavir crushed versus whole tablets in children. J Acquir Immune Defic Syndr 58:385-91
Rakhmanina, Natella Y; van den Anker, John N; Soldin, Steven J et al. (2010) Can therapeutic drug monitoring improve pharmacotherapy of HIV infection in adolescents? Ther Drug Monit 32:273-81
Rakhmanina, Natella Y; van den Anker, John N (2010) Treating an HIV-infected paediatric patient: an easy task? Antivir Ther 15:293-6
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
Rakhmanina, Natella Y; van den Anker, John N (2010) Efavirenz in the therapy of HIV infection. Expert Opin Drug Metab Toxicol 6:95-103
Khan, M; Song, X; Williams, K et al. (2009) Evaluating adherence to medication in children and adolescents with HIV. Arch Dis Child 94:970-3
Allegaert, Karel; Vanhaesebrouck, Sophie; Verbesselt, Rene et al. (2009) In vivo glucuronidation activity of drugs in neonates: extensive interindividual variability despite their young age. Ther Drug Monit 31:411-5
Knibbe, Catherijne A J; Krekels, Elke H J; van den Anker, Johannes N et al. (2009) Morphine glucuronidation in preterm neonates, infants and children younger than 3 years. Clin Pharmacokinet 48:371-85

Showing the most recent 10 out of 40 publications