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、数据分析和解释的研究者 在临床前（离体和体内）、临床、化学预防和流行病学研究中，成本低至 可能的。自上次提交以来，CPSR 修改了其人员配置，现在由一名 临床药理学家、一名研究助理和部分第二研究助理、一名研究护理人员 资源，也是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（例如细胞/肿瘤组织/血浆/唾液/尿液）和作为一部分获得的细胞样本 批准的临床和流行病学协议：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）、记录和储存、等分以及 邮寄； 2) (a) 开发新的药物检测方法（当此类检测方法无法常规使用时） HPLC（UV/荧光检测）或 LC-MS/MS 方法，(b) 药物浓度性能 用于临床前和临床肿瘤学研究的生物体液和组织测量； 3） (a) 关于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) I期和原理验证研究护理支持服务； 5） 应用于癌症药物研究的药物基因组学 (PGx) 测定和专业知识； 6) 研究药房 为肿瘤药物研究提供市售和研究性新药服务。 CPSR 目前为 13 名 NCCC 调查员提供了价值 118,881 美元的退款服务 2007 财年。NCCC 成员占达特茅斯使用该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%。该核心的退款总额为 130,161 美元 2007 财年，总运营预算为 397,951 美元，需要 267,789 美元的非退款 补助金，源自 NCCC CCSG 和向其他赞助商退款的组合 项目。该共享资源要求 NCCC CCSG 第一年提供 109,722 美元的预算 此次竞争性更新（2008-09），代表了与当年支持水平相当的水平，这将 提供 39% 的非退款补贴需求，而大部分成本通过 退款和其他机构支持。该核心补助预算和其他补助来源 主要向 NCCC 个别调查员承保部分退款费用，并提供 对该共享资源的监督提供行政支持。