CLINICAL PHARMACOLOGY SHARED RESOURCE

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The primary function of the Clinical Pharmacology Shared Resource (CPSR) is to support NCCC investigators in the design, performance, data analysis, and interpretation of clinical pharmacology objectives in preclinical (ex-vivo and in vivo), clinical, chemoprevention, and epidemiological studies, at as low a cost as possible. The CPSR has modified its staffing since the last submission such that it now consists of one clinical pharmacologist, one research assistant and a part of a second research assistant, a research nursing resource, and a part of a research pharmacist. The major CPSR services include: 1) Central processing for biological tissue samples (e.g. cells/tumor tissue/plasma/saliva/urine) and cell samples obtained as part of approved clinical and epidemiological protocols: these services include, but are not limited to, sampleprocessing (including processing peripheral blood mononuclear cells), logging and storage, aliquoting, and mail-outs; 2) (a) Development of novel drug assays (when such assays are not routinely available) using either HPLC (UV/Fluorescence detection) or LC-MS/MS methodology, (b) Performance of drugconcentration measurements in biological fluids and tissues for preclinical and clinical oncology studies; 3) (a) Consultation concerning study design and pharmacokinetic and pharmacodynamic hypothesis-testing in preclinical and clinical studies, (b) Pharmacokinetic and pharmacodynamic data analysis and modeling from pre-clinical and clinical studies; 4) Phase-l and proof-of-principle study research nursing support services; 5) Pharmacogenomic (PGx) assays and expertise applied to cancer drug research; and 6) Research Pharmacy Service for oncology drug research with commercially available and investigational new drugs. The CPSR currently provides 13 NCCC investigators with services valued at $118,881 in chargebacks for FY 2007. NCCC members represent 76% of the total number of investigators using this facility at Dartmouth, and their usage constitutes 87% of total CPSR usage. The total chargebacks for this core were $130,161 during FY2007, and the total operating budget was $397,951, requiring $267,789 in non-chargeback subvention, which is derived from a combination of the NCCC CCSG and chargebacks to other sponsored projects. This shared resource is requesting a budget of $109,722 from the NCCC CCSG for the first year of this competitive renewal (2008-09), representing a level comparable to the current year's support, which will provide 39% of its non-chargeback subvention needs, while the majority of costs are recovered through chargebacks and other institutional support. This core grant budget and the other subvention sources primarily underwrite a portion of the chargeback costs to individual NCCC investigators and provide administrative support for oversight of this shared resource.