Clinical Pharmacology (CP)

临床药理学（CP）

• 批准号: 10311226
• 负责人: LIONEL David LEWIS
• 金额: $ 10.99万
• 依托单位: DARTMOUTH COLLEGE
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-08-04 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10311226
• 关键词: Biological Assay; Budgets; Cancer Center Support Grant; Cells; Clinical; Clinical Cancer Center; Clinical Oncology; Clinical Pharmacology; Clinical Research; Concentration measurement; Consultations; DNA; Data Analyses; Development; Drug Combinations; Drug Kinetics; Epidemiology; Faculty; Fluorescence; Funding; High Pressure Liquid Chromatography; Investigation; Investigational Drugs; Investigational New Drug Application; Investigational Therapies; Malignant Neoplasms; Molecular; Norris Cotton Cancer Center; Oncology; Performance; Peripheral Blood Mononuclear Cell; Pharmaceutical Preparations; Pharmaceutical Services; Pharmacists; Pharmacodynamics; Pharmacology; Pharmacology Shared Resource; Pharmacy facility; Phase; Plasma; Pre-Clinical Model; Protocols documentation; Research; Research Assistant; Research Design; Research Methodology; Research Personnel; Saliva; Sampling; Services; Site; Testing; Therapeutic; Therapeutic Studies; Tumor Tissue; Urine; cost; data modeling; design; detection method; epidemiology study; in vivo; liquid chromatography mass spectrometry; member; novel; operation; pharmacodynamic model; pharmacokinetics and pharmacodynamics; pre-clinical; preclinical study; programs; translational therapeutics; ultraviolet

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.

项目摘要/摘要：临床药理学 临床药理学（CP）共享资源处于运营的24年，并支持Norris Cotton 癌症中心（NCCC）研究人员的设计，性能，数据分析和解释 临床前的药理学目标（体内和体内），最低的临床和流行病学研究 成本和最高价值。主要CP服务是四个领域：（1a）新颖的发展 分析物测定（仅作为研究方法可用时）越来越多地使用任何一种液体 色谱质谱法（LC-MS/MS）或高性能液相色谱（HPLC） 超紫和/或荧光检测方法； （1B）分析物浓度测量的性能 在临床前和临床肿瘤学研究的生物测量中，使用这些经过验证的生物分析测定法； （2a） 有关研究设计和药代动力学（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中进行建模； （3）生物测量的中央加工（例如细胞，肿瘤 作为批准的临床和流行病学方案的一部分获得的组织，血浆，唾液，尿液，DNA）； 包括：样品记录，加工（包括处理外周血单核细胞）的服务， 必要时进行等分，存储和样品分布； （4）癌症研究药房服务 在研究新药下使用市售药物和药物的治疗临床研究 应用。 CP由Lionel D. Lewis博士指导，他在临床表现方面建立了专业知识 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教职员工， 研究助理LAB经理，扩大了生物分析和生物测量管理专业知识，以及 研究药剂师具有肿瘤学和研究药物药房专业知识。在1/1/15期间 11/30/18，所有4个NCCC计划的NCCC成员都使用了CP共享资源，其中9个是 当前成员在3个程序中（CPS [2]，CBT [6]和ICI [1]）。 NCCC资助的会员用途代表93％ 总使用情况（42个项目），我们要求CCSG支持中CP总运营预算的78％。