Pharmacology

药理学核心的使命是提供最先进的技术和专业知识的生物分析， 药代动力学和药物遗传学，用于评价临床前关键药理学终点 和早期临床研究。两项服务，包括药代动力学/药效学（PK/PD） 自2004年起提供样本处理和分发服务以及生物分析服务。的 PK/PD样本处理和分发服务为临床试验提供支持，包括样本 运输、清点、加工、储存和分配，符合适用标准 操作规程（SOP）、IRB批准的方案和法规要求。生物分析 服务提供生物样品中药物和代谢物的定量测量（例如，血， 血浆、血清、尿液或组织样品），使用高效液相色谱法（HPLC）偶联 用紫外或荧光检测或串联质谱仪检测（LC-MS/MS）。此外，本发明还提供了一种方法， 最近开发了三条新的服务线，以便为KCI调查人员提供全面的 药理学支持这些新的服务包括：1）生物分析方法的开发和验证 一项服务，包括评估所有程序的准确度、精密度、选择性、灵敏度、再现性 特定HPLC或LC-MS/MS方法的稳定性; 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 开发以及使用传统或人群分析和解释药代动力学数据 药代动力学建模方法;和3）药物遗传学分析是与 基因组学核心，重点是采用候选基因的方法来检查之间的关联 在选定的基因（如编码药物的基因）中的常见单核苷酸多态性（SNP 代谢酶、转运蛋白或靶受体/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... 现有的分析仪器如LC-MS/MS。可用的药代动力学分析软件包括 WinNonlin版本5.2和NONMEM版本6。实验室位于市中心，交通方便 为KCI调查员准备的

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.