Pharmacology

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The Pharmacology Core's mission is to provide state-of-the-art technology and expertise in bioanalysis, pharmacokinetics, and pharmacogenetics for evaluation of critical pharmacological endpoints in preclinical and eariy phase clinical studies. Two services, including pharmacokinetic/pharmacodynamic (PK/PD) sample processing and distribution service and bioanalysis service, have been provided since 2004. The PK/PD sample processing and distribution service provides support for clinical trials, including specimen transport, accountability, processing, storage, and distribution, in compliance with applicable Standard Operating Procedures (SOPs), IRB-approved protocols, and regulatory requirements. The bioanalysis service provides quantitative measurement of drugs and metabolites in biological samples (e.g., blood, plasma, serum, urine, or tissue samples) using high-performance liquid chromatography (HPLC) coupled with ultraviolet or fluorescence detection or tandem mass spectrometer detection (LC-MS/MS). In addition, three new service lines were recently developed in order to provide KCI investigators with comprehensive pharmacology support. These new services include: 1) bioanalytical methods development and validation service that includes evaluating all procedures for accuracy, precision, selectivity, sensitivity, reproducibility and stability of a particular HPLC or LC-MS/MS method; 2) pharmacokinetic data analysis and modeling service that provides assistance in preclinical and clinical pharmacokinetic experimental design and protocol development as well as analysis and interpretation of pharmacokinetic data using traditional or population pharmacokinetic modeling approaches; and 3) pharmacogenetic analysis is a collaborative service with the Genomics Core that focuses on employing a candidate gene approach to examine the associations between common single nucleotide polymorphisms (SNPs) in selected genes (such as genes encoding drug metabolizing enzymes, transporters, or target receptors/enzymes) and PK parameters, PD effects, or clinical outcome (efficacy or toxicity) of clinical investigational anticancer agents. The Core is equipped with stateof- the-art analytical instruments such as LC-MS/MS. Available pharmacokinetic analysis software includes WinNonlin version 5.2 and NONMEM version 6. The laboratory is centrally located with convenient access forthe KCI investigators.