The Pharmaceutical Research Shared Resource provides a broad spectrum of pharmacological and pharmaceutical services essential to conduct of preclinical and clinical research in cancer biology, drug discovery, drug evaluation, and related areas by members of the Duke Cancer Institute (DCI). It is composed of two services: the Investigational Chemotherapy Service (ICS) and the Pharmacokinetics/ Pharmacodynamics (PK/PD) service. The ICS prepares investigational drug products, maintains drug accountability records and investigational drug inventories according to FDA and CTEP guidelines, provides design consultation, professional staff education, and implementation services for clinical research studies. Managed by and integral with the Department of Pharmacy, the ICS is staffed by a clinical pharmacist, a clinical research coordinator and clinical research specialist. ICS, which has provided services to the DCI for over 20 years, is located in the new Duke Cancer Center building adjacent to the Department of Pharmacy Cancer Center Infusion Pharmacy. PK/PD services are provided by the PK/PD Core which is located in a custom-designed analytical laboratory area contiguous with the new Duke Cancer Center building. It is managed by DCI and is equipped with state-of-the-art analytical and computational equipment. PK/PD services are based on the following primary technologies: liquid chromatography - tandem-mass spectroscopy (LC- MS/MS), HPLC-fluorescence, HPLC-UV/vis, and fluorescence/UV/vis plate readers for ELISA assays. These technologies cover 99% of any need on campus for small molecule (drugs, drug-metabolites, metabolome, biomarkers) analysis in cell culture, bodily fluids, or tissues. The Shared Resource provides cost-effective access to DCI members for key early activities related to drug development: investigational drug preparation/dispensing and PK/PD testing. The ICS is supporting more than 200 active clinical studies currently, and the PK/PD service has served 35 investigators' laboratories since 2009, including 24 DCI members' labs (representing seven of the nine CCSG-recognized Research Programs); 15 (63%) of the DCI users have peer-reviewed funding. Since 2009, Duke investigators have published 75 papers utilizing data from studies managed by the ICS and 63 papers (36 from clinical research) utilizing PK/PD data obtained through the Shared Resource.
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