The Pharmaceutical Research Shared Resource, consisting of an Investigational Chemotherapy Service and a Cancer Clinical Pharmacology Laboratory, provides a broad range of services to support the conduct of clinical hematology/oncology research. The Investigafional Chemotherapy Service (ICS) is available to all Duke Cancer Institute investigators for the purpose of maintaining drug accountability records and investigafional drug Inventories according to FDA and CTEP guidelines. In addition, this resource provides design consultafion, professional staff educafion, and implementafion services for clinical research studies. The primary focus ofthe Clinical Pharmacology Lab (GPL) is to invesfigate the pharmacokinefics and pharmacodynamics of anticancer drugs and recombinant proteins used in the experimental therapy of cancer. This resource is also available for analysis of endogenous cytokine concentrations during investigational therapy. One of the major goals of the laboratory is to identify predictors of resppnse and toxicity and implement methods to reduce inter-patient variability and drug exposure. The lab provides both consultative and analytic services regarding clinical pharmacokinetic studies of anticancer compounds and recombinant proteins. These include: aid with trial design, opfimal sampling techniques, sample handling and stability, quantitative measurement of drug and metabolite concentrafions (via HPLC, atomic absorpfion spectrophotometry, gas chromatography/mass spectrophotometry, or ELISA), calculation of individual and populafion pharmacokinetic parameters and pharmacometric evaluafion via sophisficated computer modeling programs. This resource has maintained a high level of usage by Duke Cancer Institute investigators including those from the Experimental Therapeutics Program, Breast arid Ovarian Oncology, Hematopoietic Transplantafion and Hematologic Malignancies, Neuro-Oncology, Radiation, and Cancer Biology Programs.
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