Pharmacology

药理学核心的使命是提供最先进的生物分析技术和专业知识， 临床前评估关键药理学终点的药代动力学和药物遗传学 以及早期的临床研究。两项服务，包括药代动力学/药效学(PK/PD) 自2004年以来，一直提供样品加工和分发服务以及生物分析服务。这个 PK/PD样本处理和分发服务为临床试验提供支持，包括样本 符合适用标准的运输、责任、处理、存储和分发 操作程序(SOP)、IRB批准的协议和法规要求。生物分析 该服务提供对生物样本(例如，血液， 血浆、血清、尿液或组织样本) 用紫外或荧光检测或串联质谱仪检测(LC-MS/MS)。此外, 最近开发了三条新的服务线路，为KCI调查人员提供全面的 药理学支持。这些新服务包括：1)生物分析方法的开发和验证 包括评估所有程序的准确性、精密度、选择性、灵敏度、重复性的服务 和稳定性；2)药代动力学数据分析和建模 在临床前和临床药代动力学实验设计和方案方面提供帮助的服务 利用传统或群体开发以及分析和解释药代动力学数据 药代动力学建模方法；以及3)药物遗传学分析是与 基因组学核心，专注于使用候选基因方法来检查 选定基因(如编码药物的基因)的常见单核苷酸多态(SNPs) 代谢酶、转运体或靶受体/酶)和PK参数、PD效应或临床 临床研究抗癌药物的结果(疗效或毒性)。核心配备了状态- 先进的分析仪器，如LC-MS/MS。现有的药代动力学分析软件包括 WinNonlin版本5.2和NONMEM版本6。实验室位于中心位置，访问方便 给KCI的调查员。

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.