Clinical Pharmacology (CP)

项目摘要/摘要：临床药理学 临床药理学(CP)共享资源已运行24年，支持Norris Cotton 癌症中心(NCCC)的研究人员参与设计、性能、数据分析和解释 临床前(体内和体外)、临床和流行病学研究的药理学目标最低 成本和尽可能高的价值。主要的CP业务有四个领域：(1)开发新的 分析物分析(当这种分析只作为研究方法可用时)越来越多地使用液体- 色谱质谱联用(LC-MS/MS)或高效液相色谱(HPLC) 紫外线和/或荧光检测方法；(1b)分析物浓度测量的性能 来自临床前和临床肿瘤学研究的生物样本，使用这些经过验证的生物分析方法；(2a) 关于研究设计和药代动力学(PK)和药效学(PD)假说的专家咨询- 临床前和临床癌症研究的开发和测试；(2b)PK和Pd数据分析和PK-Pd 来自临床前和临床研究的建模；(3)生物样品(例如细胞、肿瘤)的中央处理 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； 服务内容包括：样品采集、加工(包括外周血单核细胞加工)、 (4)癌症研究药房服务 市售药物和研究用新药的临床治疗研究 申请。CP由莱昂内尔·D·刘易斯博士执导，他在临床表现方面拥有丰富的专业知识 PK和PD用于研究肿瘤学药物或药物/药物组合的早期临床研究。其他 工作人员包括一名具有生物分析和分子药理学专业知识的初级学院药剂师， 研究助理-实验室经理，具有不断扩展的生物分析和生物显微镜管理专业知识，以及 具有肿瘤学和研究药物药剂学专业知识的研究药剂师。在1/1/15至 11/30/18，来自所有4个NCCC计划的15个NCCC成员使用了CP共享资源，其中9个是 目前是3个计划(CPS[2]、CBT[6]和ICI[1])的成员。NCCC资助的会员使用率为93% 占总使用量的78%(42个项目)，我们要求CCSG支持部门提供总运营预算的78%。

Project Summary/Abstract: Clinical Pharmacology The Clinical Pharmacology (CP) Shared Resource is in its 24th year of operation and supports 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 and epidemiological studies at the lowest cost and highest value possible. The major CP services are in four domains: (1a) Development of novel analyte assays (when such assays are only available as research methods) increasingly using either liquid- chromatography mass spectrometry (LC-MS/MS) or high performance liquid chromatography (HPLC) with ultra-violet and/or fluorescence detection methods; (1b) Performance of analyte-concentration measurements in biospecimens from preclinical and clinical oncology studies using these validated bioanalytical assays; (2a) Expert consultation regarding study design and pharmacokinetic (PK) and pharmacodynamic (PD) hypothesis- development and testing in preclinical and clinical cancer studies; (2b) PK and PD data analysis and PK-PD modeling from pre-clinical and clinical studies; (3) Central processing for biospecimens (e.g., cells, tumor tissue, plasma, saliva, urine, DNA) obtained as part of approved clinical and epidemiological protocols; services that include: sample logging, processing (including processing peripheral blood mononuclear cells), aliquoting, storage and sample distribution when necessary; and (4) Research pharmacy services for cancer therapeutic clinical studies with both commercially available drugs and drugs under an investigational new drug application. CP is directed by Dr. Lionel D. Lewis, who has established expertise in the clinical performance of PK and PD for early phase clinical studies of investigational oncology drug or drug/drug combinations. Other staff includes a junior faculty pharmacologist with bioanalytical and molecular pharmacology expertise, a research assistant-lab manager with expanding bioanalytical and biospecimen stewardship expertise, and a research pharmacist with expertise in oncologic and investigational drug pharmacy. During the period 1/1/15 to 11/30/18, 15 NCCC Members from all 4 NCCC Programs utilized the CP Shared Resource, 9 of whom are current Members in 3 Programs (CPS [2], CBT [6], and ICI [1]). NCCC Funded Member Use represented 93% of Total Use (42 Projects), and we are requesting 78% of the CP Total Operating Budget from CCSG support.