Clinical Pharmacology (CP)

项目摘要/摘要：临床药理学(CP) 临床药理学(CP)共享资源现已进入第19个年头，主要功能 为诺里斯棉花癌症中心(NCCC)的研究人员提供设计、性能、数据分析和 临床前(体内和体外)、临床、化学预防和 流行病学研究，以尽可能低的成本和最高的价值。主要的CPSR服务有4个 领域：(1)生物液体和组织(例如，细胞、肿瘤组织、血浆、唾液、尿液、 DNA)作为批准的临床和流行病学方案的一部分获得；包括但不包括的服务 仅限于样品记录、处理(包括处理外周血单核细胞)、等分、 必要时储存和分发样品；(2a)开发新的分析物分析方法(在此情况下 检测仅作为研究方法)使用高效液相色谱(Hplc) 用紫外光(UV)和/或荧光检测，或越来越多的液相色谱质谱 (LC-MS/MS)方法学；(2b)生物液体和 使用这些经过验证的生物分析方法进行临床前和临床肿瘤学研究的组织；(3a)专家 关于研究设计以及药代动力学和药效学假说的开发和 临床前和临床癌症研究中的测试；(3b)药代动力学(PK)和药效学(PD)数据 临床前和临床研究的分析和PK-PD建模；以及(4)研究药房服务 用市售药物和正在研究的药物进行的癌症治疗临床研究 新药申请(IND)。CP由莱昂内尔·D·刘易斯博士执导，他在临床上拥有丰富的专业知识 阿司匹林早期临床研究的表现、药代动力学和药效学 研究肿瘤学药物/药物组合。其他工作人员包括一名初级教职药剂师 生物分析和分子药理学专业知识，研究助理-生物库实验室经理和 生物分析专业知识，以及一名具有肿瘤学和研究药物专业知识的研究药剂师 药房。在2012年12月1日至2013年11月30日期间，分子治疗学会成员 计划是CP服务最常见和最频繁的用户，占使用的60%。然而，CP 为其他NCCC计划成员提供重要服务。癌症流行病学(CE)成员 代表8.5%的用户，癌症机制(CM)成员代表8.5%的用户，免疫学 和癌症免疫治疗(ICI)计划成员占用户的17%。

Project Summary/Abstract: Clinical Pharmacology (CP) The Clinical Pharmacology (CP) Shared Resource is now in its 19th year of operation and primarily functions to support Norris Cotton Cancer Center (NCCC) investigators in the design, performance, data analysis, and interpretation of pharmacology objectives in preclinical (in vivo and ex-vivo), clinical, chemoprevention, and epidemiological studies, at lowest cost and highest value as possible. The major CPSR services are in 4 domains: (1) Central processing for biological fluids and tissues (e.g., cells, tumor tissue, plasma, saliva, urine, DNA) obtained as part of approved clinical and epidemiological protocols; services that include, but are not limited to, sample logging, processing (including processing peripheral blood mononuclear cells), aliquoting, storage and sample distribution when necessary; (2a) Development of novel analyte assays (when such assays are only available as research methods) using either high performance liquid chromatography (HPLC) with ultra-violet (UV) and/or fluorescence detection, or increasingly liquid-chromatography mass spectrometry (LC-MS/MS) methodology; (2b) Performance of analyte-concentration measurements in biological fluids and tissues for preclinical and clinical oncology studies using these validated bioanalytical assays; (3a) Expert consultation regarding study design and pharmacokinetic and pharmacodynamic hypothesis-development and testing in preclinical and clinical cancer studies; (3b) Pharmacokinetic (PK) and pharmacodynamic (PD) data analysis and PK-PD modeling from pre-clinical and clinical studies; and (4) Research pharmacy services for cancer therapeutic clinical studies with both commercially available drugs and drugs under an investigational new drug application (IND). CP is directed by Dr. Lionel D. Lewis, who has established expertise in the clinical performance, the pharmacokinetics, and the pharmacodynamics of early phase clinical studies of investigational oncology drug/drug combinations. Other staff include a junior faculty pharmacologist with bioanalytical and molecular pharmacology expertise, a research assistant-lab manager with biorepository and bioanalytical expertise, and a research pharmacist with expertise in oncologic and investigational drug pharmacy. During the period 12/01/2012 to 11/30/2013, members of the Molecular Therapeutics (MT) program were the most common and frequent users of CP services, representing 60% of use. However, CP provided important services to other NCCC program members. Cancer Epidemiology (CE) members represented 8.5% of users, Cancer Mechanisms (CM) members represented 8.5% of users, and Immunology & Cancer Immunotherapy (ICI) program members represented 17% of users.