The Cincinnati Children's Hospital Medical Center (CCHMO PPRU) Network site has developed into a premier pediatric clinical pharmacology program during the previous funding cycle, with concentrated expertise in neuropharmacology. CCHMC PPRU has either brought to the Network, or played key designlimplementation roles for every neurophamiacology protocol since 1999. It's mature development is exemplified by a pediatric clinical pharmacology fellowship training program watt, the highest concentration of board-certified pediatric clinical pharmacologists of any institution, expanded core wet and dry lab facilities, and dedicated clinical studies space to improve our program and network participation. The confluence of resources at our site include: 1) a pediatric GCRC, 2) a not-for-profit clinical trials organization and infrastructure, 3) a pediatric focused Center for Environmental Genetics, 4) a Howard Hughes Bioinformatics center, 5) a CERT (Center for Education and Research in Therapeutics), 6) a Vaccine Testing and Treatment center, 7) a Center for Epidemiology and Biostatistics, 8) a Neonatal Network site and a 9) Pharmacogenetics lab. The CHMCC PPRU is situated in newly renovated space within the Oak Clinical Research Facility and consists of contiguous 18 outpatient exam rooms (10,000 sq. ft.), core laboratory (3500 sq. ft.) and administrative (2400 sq. ft.) space while an MH funded pediatric GCRC provides inpatient capability. The CHMCC PPRU is directed by Dr. Sallee, a child psychiatrist/clinical pharmacologist, with extensive experience in all aspects of clinical trials and with existing linkages to the pharmaceutical industry and FDA. Dr. Vinks, core laboratory director and fellowship training director complements this expertise with pharmacokineticlpharmacodynarnic modeling and analytic capability. Co-investigators, Tracy Glauser (pediatirc neurologist), Phil Walson (pediatric clinical phannacologist) and Dan Nebert (pediatric clinical pharmacologist), work closely with the PPRU unit and actively contribute to protocol design, implementation, training, and educational activities. Advantages of continuing a focus on pediatric neuropharmacology is documented by our two network proposals; """"""""Pharmacogenetics of Risperidone in Pervasive Development Disorder"""""""" (Dr. Vinks; Pharmacogenetics and Pharmacodynamics of Childhood Absence Epilepsy"""""""" Dr. Glauser.

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 #
5U10HD037249-07
Application #
6854514
Study Section
Special Emphasis Panel (ZHD1-DSR-A (01))
Program Officer
Giacoia, George
Project Start
1999-01-07
Project End
2008-12-31
Budget Start
2005-01-01
Budget End
2005-12-31
Support Year
7
Fiscal Year
2005
Total Cost
$351,233
Indirect Cost
Name
Children's Hospital Med Ctr (Cincinnati)
Department
Type
DUNS #
071284913
City
Cincinnati
State
OH
Country
United States
Zip Code
45229
Glauser, Tracy A; Holland, Katherine; O'Brien, Valerie P et al. (2017) Pharmacogenetics of antiepileptic drug efficacy in childhood absence epilepsy. Ann Neurol 81:444-453
Dong, Min; Fukuda, Tsuyoshi; Cox, Shareen et al. (2014) Population pharmacokinetic-pharmacodynamic modelling of mycophenolic acid in paediatric renal transplant recipients in the early post-transplant period. Br J Clin Pharmacol 78:1102-12
Smits, Thomas A; Cox, Shareen; Fukuda, Tsuyoshi et al. (2014) Effects of unbound mycophenolic acid on inosine monophosphate dehydrogenase inhibition in pediatric kidney transplant patients. Ther Drug Monit 36:716-23
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
Glauser, Tracy A; Cnaan, Avital; Shinnar, Shlomo et al. (2013) Ethosuximide, valproic acid, and lamotrigine in childhood absence epilepsy: initial monotherapy outcomes at 12 months. Epilepsia 54:141-55
Fukuda, Tsuyoshi; Goebel, Jens; Cox, Shareen et al. (2012) UGT1A9, UGT2B7, and MRP2 genotypes can predict mycophenolic acid pharmacokinetic variability in pediatric kidney transplant recipients. Ther Drug Monit 34:671-9
Ngamprasertwong, Pornswan; Vinks, Alexander A; Boat, Anne (2012) Update in fetal anesthesia for the ex utero intrapartum treatment (EXIT) procedure. Int Anesthesiol Clin 50:26-40
Sherwin, Catherine M T; Sagcal-Gironella, Anna Carmela P; Fukuda, Tsuyoshi et al. (2012) Development of population PK model with enterohepatic circulation for mycophenolic acid in patients with childhood-onset systemic lupus erythematosus. Br J Clin Pharmacol 73:727-40
Sherwin, Catherine M T; Saldaña, Shannon N; Bies, Robert R et al. (2012) Population pharmacokinetic modeling of risperidone and 9-hydroxyrisperidone to estimate CYP2D6 subpopulations in children and adolescents. Ther Drug Monit 34:535-44
Fukuda, Tsuyoshi; Goebel, Jens; Thøgersen, Håvard et al. (2011) Inosine monophosphate dehydrogenase (IMPDH) activity as a pharmacodynamic biomarker of mycophenolic acid effects in pediatric kidney transplant recipients. J Clin Pharmacol 51:309-20

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