The overall objective of the UCSD/CHHC Pediatric Pharmacology Research Unit (PPRU) is to engage in studies of drugs with proven or potential activity which will lead to safe and effective therapeutic use in infants and children. This will be accomplished through careful collaborative planning and adherence to FDA guidelines so that drug files assembled during development and conduct of PPRU studies can provide sufficient data for licensing of new (or old) drugs for pediatric indications at safe, effective doses. A significant portion of this mission will be accomplished in collaboration with pharmaceutical industry so that a direct, tangible consequence of the studies performed will be to increase the number of drugs which are labeled for pediatric use and expand pediatric labeling to all pediatric populations, including newborns, so that all pediatric patients may receive intelligent and rational science-based therapy. The scope of the PPRU grant is to provide an organizational and operational infrastructure at UCSD and Children's Hospital of San Diego to implement the following specific aims: 1. To provide a locus for the conduct of studies in bioavailability, formulations, drug metabolism, pharmacokinetics, pharmacodynamics, safety and effectiveness of new drugs and drugs already in the market. 2. To gather or promote the accrual of necessary clinical data for pediatric age-specific labeling of drugs. Studies of widely used off-patent drugs and drugs used in the newborn population will be of high priority. 3. To carry out research on novel approaches and innovations in pediatric pharmacology. Specific areas of interest include, but are not limited to: a. Identification, development, validation and or extrapolation from adult studies of biomarkers of diagnosis, prognosis, efficacy, toxicity and of disease activity; b) Development and validation of non-invasive pharmacodynamic measurements; c) Development and/or adaptation of novel pharmacokinetic-pharmacodynamic modeling technology in pediatrics (e.g. mechanistic and physiologic based pharmacokinetics); d) Use of new molecular approaches; e)Applications of new drug delivery systems to pediatric therapy. 4. To implement studies of the developmental characteristics and genetic polymorphisms of drug metabolizing enzymes (DMEs), transporters, and receptors and describe phenotypic-genotypic correlations. 5. To apply pharmacogenomic and proteonomic tools in clinical studies. 6. To provide a training and educational program in clinical and developmental pharmacology.

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 #
5U10HD031318-13
Application #
7013131
Study Section
Special Emphasis Panel (ZHD1-DSR-A (01))
Program Officer
Giacoia, George
Project Start
1994-01-01
Project End
2008-12-31
Budget Start
2006-01-01
Budget End
2006-12-31
Support Year
13
Fiscal Year
2006
Total Cost
$392,400
Indirect Cost
Name
University of California San Diego
Department
Pediatrics
Type
Schools of Medicine
DUNS #
804355790
City
La Jolla
State
CA
Country
United States
Zip Code
92093
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
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
Best, Brookie M; Letendre, Scott L; Koopmans, Peter et al. (2012) Low cerebrospinal fluid concentrations of the nucleotide HIV reverse transcriptase inhibitor, tenofovir. J Acquir Immune Defic Syndr 59:376-81
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
Best, Brookie M; Koopmans, Peter P; Letendre, Scott L et al. (2011) Efavirenz concentrations in CSF exceed IC50 for wild-type HIV. J Antimicrob Chemother 66:354-7
Glauser, Tracy A; Cnaan, Avital; Shinnar, Shlomo et al. (2010) Ethosuximide, valproic acid, and lamotrigine in childhood absence epilepsy. N Engl J Med 362:790-9
Best, Brookie M; Letendre, Scott L; Brigid, Eileen et al. (2009) Low atazanavir concentrations in cerebrospinal fluid. AIDS 23:83-7
Mirochnick, Mark; Thomas, Timothy; Capparelli, Edmund et al. (2009) Antiretroviral concentrations in breast-feeding infants of mothers receiving highly active antiretroviral therapy. Antimicrob Agents Chemother 53:1170-6
Capparelli, E V; Aweeka, F; Hitti, J et al. (2008) Chronic administration of nevirapine during pregnancy: impact of pregnancy on pharmacokinetics. HIV Med 9:214-20
Burns, Jane C; Best, Brookie M; Mejias, Asuncion et al. (2008) Infliximab treatment of intravenous immunoglobulin-resistant Kawasaki disease. J Pediatr 153:833-8

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