CLINICAL PHARMACOLOGY SHARED RESOURCE

临床药理学共享资源（CPSR）的主要功能是支持NCCC 研究者在临床药理学目标的设计、性能、数据分析和解释方面 在临床前（离体和体内）、临床、化学预防和流行病学研究中， 可能自上次提交报告以来，委员会已调整了人员配置， 临床药理学家，一名研究助理和第二名研究助理的一部分，一名研究护理人员 资源，和一个研究药剂师的一部分。CPSR的主要服务包括：1）中央处理 生物组织样品（例如细胞/肿瘤组织/血浆/唾液/尿液）和作为 经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）、记录和储存、等分，以及 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）药物浓缩性能 用于临床前和临床肿瘤学研究的生物液体和组织中的测量; 3） (a)关于研究设计和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） 药物基因组学（PGx）分析和应用于癌症药物研究的专业知识;以及6）研究药学 为上市新药和研究新药提供肿瘤药物研究服务。 CPSR目前为13名NCCC调查员提供价值118，881美元的退款服务， 2007财政年度。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%。此核心的总退款为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，来自NCCC CCSG和其他赞助商的退款 项目这一共享资源要求NCCC CCSG为2010年的第一年提供109，722美元的预算。 这次竞争性续约（2008-09），相当于本年度的支持水平， 提供39%的非退款补助金需求，而大部分成本则通过 退款和其他机构支持。这一核心赠款预算和其他补助金来源 主要承保一部分费用退还给个别NCCC调查员，并提供 为监督这一共享资源提供行政支助。

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.