? PHARMACOKINETICS AND INVESTIGATIONAL CHEMOTHERAPY SHARED RESOURCE The primary purpose of the Pharmacokinetics and Investigational Chemotherapy (PKIC) shared resource, considered a clinical research-oriented facility, is to provide a broad spectrum of pharmacological and pharmaceutical services essential to the conduct of preclinical and clinical research in oncology, drug discovery, drug evaluation, and related areas to members of the Duke Cancer Institute (DCI). DCI members receive priority access at all stages of support. The PKIC is composed of two services: the Pharmacokinetics/ Pharmacodynamics (PK/PD) service and the Investigational Chemotherapy Service (ICS). The Pharmacokinetics/Pharmacodynamics (PK/PD) services are provided by the PK/PD Core in support of Phase I/II clinical studies (study design, dosing regimen, plasma/tissue biopsy, PK analysis/modeling, results reporting and publication), as well as early translational/preclinical cancer drug development work (new drug candidate chemical and metabolic properties, drug formulation, bioanalytical assay development, plasma/tissue analysis, PK/PD modeling, and dosing regimen optimization for efficacy studies). In addition, the expertise and instrumentation for handling complex bio-fluids/tissue matrices is available for analysis of small molecules in a broad sense, thus complementing other bioanalytical resources in supporting mechanistic and biomarker cancer studies. The Investigational Chemotherapy Service (ICS) is available to all DCI investigators for preparing investigational drug products, maintaining drug accountability records and investigational drug inventories according to FDA and CTEP guidelines. ICS supports all phases of clinical research and utilizes USP797 and USP800 cleanrooms for sterile study drug preparation. ICS prepares hazardous, non-hazardous and viral vector study drugs. In addition, this service provides design consultation, professional staff education, and implementation services for clinical research studies. In 2018, the PKIC (PKPD/ICS) provided services to 86 (22/66) investigators, 81% (77%/83%) of whom were DCI members, accounting for 84% of total usage, from all 8 DCI Research Programs. Use of this shared resource by DCI Members contributed to 70 publications over the project period, 11 of which were in high impact journals (Impact Factor > 9), demonstrating the value of services offered by the resource.
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