Clinical Pharmacology (CP)

项目总结/摘要：临床药理学 临床药理学（CP）共享资源已运营24年，并支持Norris Cotton 癌症中心（NCCC）的研究人员在设计，性能，数据分析和解释， 临床前（体内和离体）、临床和流行病学研究中的药理学目标 成本和最高价值。主要的CP服务分为四个领域：（1a）小说开发 分析物测定（当这种测定仅可用作研究方法时）越来越多地使用液体- 色谱-质谱法（LC-MS/MS）或高效液相色谱法（HPLC）， 紫外和/或荧光检测方法;（1b）分析物浓度测量的性能 在使用这些经验证的生物分析测定法进行的临床前和临床肿瘤学研究的生物标本中;（2a） 关于研究设计以及药代动力学（PK）和药效学（PD）假设的专家咨询- 临床前和临床癌症研究中的开发和测试;（2b）PK和PD数据分析以及PK-PD 从临床前和临床研究建模;（3）生物样本的中央处理（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; 服务包括：样本记录，处理（包括处理外周血单核细胞）， （4）癌症研究药剂服务 使用市售药物和试验性新药的治疗性临床研究 应用程序. CP由莱昂内尔D博士指导。刘易斯，谁建立了专业知识的临床表现， 研究性肿瘤药物或药物/药物组合的早期临床研究的PK和PD。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药理学家， 研究助理-实验室经理，具有不断扩展的生物分析和生物标本管理专业知识，以及 具有肿瘤学和研究药物药学专业知识的研究药剂师。在2015年1月1日至 2018年11月30日，来自所有4个NCCC计划的15名NCCC成员利用了CP共享资源，其中9人是 目前在3个程序（CPS [2]，CBT [6]和ICI [1]）的成员。NCCC资助的会员使用占93% 我们要求CCSG支持CP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.