CLINICAL PHARMACOLOGY SHARED RESOURCE

临床药理学共享资源

• 批准号: 7944619
• 负责人: LIONEL David LEWIS
• 金额: $ 15.14万
• 依托单位: DARTMOUTH COLLEGE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-21 至 2013-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7944619
• 关键词: Aliquot; Animals; Antineoplastic Agents; Applications Grants; Arts; Back; Bar Codes; Biological; Biological Assay; Biological Process; Budgets; CYP2C9 gene; CYP2D6 gene; Calcium; Cancer Center; Cancer Center Support Grant; Cells; Clinical; Clinical Chemoprevention; Clinical Oncology; Clinical Pharmacology; Clinical Protocols; Clinical Research; Clinical Trials; Computers; Concentration measurement; Consultations; Data; Data Analyses; Databases; Detection; Development; Documentation; Drug Kinetics; Enrollment; Epidemiologic Studies; Epidemiology; Etoposide; Evaluation; Evaluation Studies; Fluorescence; Folate; Funding; Future; Genetic Polymorphism; Hemoglobin; High Pressure Liquid Chromatography; In Vitro; Individual; Investigational Drugs; Kynurenine; Laboratory Research; Leadership; Learning; Liquid substance; Mails; Malignant Neoplasms; Measurement; Measures; Methodology; Modeling; Molecular Biology; Monitor; Norris Cotton Cancer Center; Nursing Research; Oncology Group; Patient Care; Patients; Performance; Peripheral Blood Mononuclear Cell; Pharmaceutical Preparations; Pharmaceutical Services; Pharmacists; Pharmacodynamics; Pharmacogenetics; Pharmacogenomics; Pharmacology Shared Resource; Pharmacotherapy; Pharmacy facility; Phase; Pilot Projects; Plasma; Pre-Clinical Model; Printing; Process; Protocols documentation; Reader; Research; Research Design; Research Personnel; Resource Sharing; Resources; Saliva; Sampling; Scanning; Services; Source; Specimen; System; Technology; Testing; Therapeutic Studies; Tissue Sample; Tissues; Tryptophan; Tumor Tissue; Urine; Work; Zebra; anticancer research; biobank; cost; design; docetaxel; in vivo; member; novel; oncology; pre-clinical; preclinical study; repository; research study; tumor; volunteer

The primary function of the Clinical Pharmacology Shared Resource (CPSR) is to support NCCC investigators in the design, performance, data analysis, and interpretation of clinical pharmacology objectives in preclinical (ex-vivo and in vivo), clinical, chemoprevention, and epidemiological studies, at as low a cost as possible. The CPSR has modified its staffing since the last submission such that it now consists of one clinical pharmacologist, one research assistant and a part of a second research assistant, a research nursing resource, and a part of a research pharmacist. The major CPSR services include: 1) Central processing for biological tissue samples (e.g. cells/tumor tissue/plasma/saliva/urine) and cell samples obtained as part of approved clinical and epidemiological protocols: these services include, but are not limited to, sampleprocessing (including processing peripheral blood mononuclear cells), logging and storage, aliquoting, and mail-outs; 2) (a) Development of novel drug assays (when such assays are not routinely available) using either HPLC (UV/Fluorescence detection) or LC-MS/MS methodology, (b) Performance of drugconcentration measurements in biological fluids and tissues for preclinical and clinical oncology studies; 3) (a) Consultation concerning study design and pharmacokinetic and pharmacodynamic hypothesis-testing in preclinical and clinical studies, (b) Pharmacokinetic and pharmacodynamic data analysis and modeling from pre-clinical and clinical studies; 4) Phase-l and proof-of-principle study research nursing support services; 5) Pharmacogenomic (PGx) assays and expertise applied to cancer drug research; and 6) Research Pharmacy Service for oncology drug research with commercially available and investigational new drugs. The CPSR currently provides 13 NCCC investigators with services valued at $118,881 in chargebacks for FY 2007. NCCC members represent 76% of the total number of investigators using this facility at Dartmouth, and their usage constitutes 87% of total CPSR usage. The total chargebacks for this core were $130,161 during FY2007, and the total operating budget was $397,951, requiring $267,789 in non-chargeback subvention, which is derived from a combination of the NCCC CCSG and chargebacks to other sponsored projects. This shared resource is requesting a budget of $109,722 from the NCCC CCSG for the first year of this competitive renewal (2008-09), representing a level comparable to the current year's support, which will provide 39% of its non-chargeback subvention needs, while the majority of costs are recovered through chargebacks and other institutional support. This core grant budget and the other subvention sources primarily underwrite a portion of the chargeback costs to individual NCCC investigators and provide administrative support for oversight of this shared resource.

临床药理学共享资源(CPSR)的主要功能是支持NCCC 临床药理学目标的设计、执行、数据分析和解释方面的研究人员 在临床前(体外和体内)、临床、化学预防和流行病学研究中，成本低至 有可能。自上次提交以来，CPSR已修改了工作人员配置，现在有一名成员。 临床药剂师，一名研究助理和第二名研究助理的一部分，研究护理 资源，以及研究药剂师的一部分。主要的CPSR服务包括：1)中央处理 生物组织样本(如细胞/肿瘤组织/血浆/唾液/尿液)和作为 批准的临床和流行病学方案：这些服务包括但不限于样本处理 (包括处理外周血单核细胞)、记录和存储、平衡和 邮寄；2)(A)开发新的药物化验(当这种化验不是常规可用时)使用 高效液相(UV/荧光检测)或LC-MS/MS方法，(B)药物浓度的表现 临床前和临床肿瘤学研究中的体液和组织测量；3) (A)关于#年研究设计以及药代动力学和药效学假设检验的咨询 临床前和临床研究，(B)药代动力学和药效学数据分析和建模 临床前和临床研究；4)L阶段和原则验证研究护理支持服务；5) 药物基因组学(PGx)分析和专业知识应用于抗癌药物研究；以及6)研究药房 为肿瘤学药物研究提供商业化和研究性新药服务。 CPSR目前为13名NCCC调查人员提供了价值118,881美元的服务，用于 2007财年。NCCC成员占使用达特茅斯这个设施的调查人员总数的76%， 它们的使用量占CPSR总使用量的87%。此核心的总退款为130,161美元 2007财年，运营预算总额为397,951美元，需要267,789美元的非按存储容量使用计费 资助金，来自NCCC CCSG和其他赞助机构的按存储容量使用计费 项目。这一共享资源要求NCCC CCSG为#年第一年提供109,722美元的预算 这一竞争性延长(2008-09)，相当于本年度支助的水平，将 提供39%的非按存储容量使用计费补贴需求，而大部分成本通过 按存储容量使用计费和其他制度支持。这项核心补助金预算和其他补助金来源 主要承保个别NCCC调查人员的部分按存储容量使用计费成本，并提供 为监督这一共享资源提供行政支持。