CLINICAL PHARMACOLOGY SHARED RESOURCE

临床药理学共享资源

基本信息

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
项目类别：
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

项目摘要

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，性能，数据分析和解释的研究者在临床前（前体和体内），临床，化学预防和流行病学研究，成本低如可能的。自上次提交以来，CPSR已修改其人员配备临床药理学家，一名研究助理和第二名研究助理的一部分，一项研究护理资源，以及研究药剂师的一部分。主要CPSR服务包括：1）中央处理生物组织样品（例如细胞/肿瘤组织/等离子体/唾液/尿液）和作为作为作为作为作为一部分的细胞样品批准的临床和流行病学方案：这些服务包括但不限于样本过程（包括处理外周血单核细胞），日志记录和存储，等分试样和邮寄； 2）（a）使用新型药物测定的开发（当不常规的情况下使用此类测定时）使用 HPLC（UV/荧光检测）或LC-MS/MS方法，（b）药物浓度的性能用于临床前和临床肿瘤学研究的生物流体和组织的测量； 3）（a）有关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）阶段-L和原则研究研究护理支持服务； 5）用于癌症药物研究的药物基因组学（PGX）测定和专业知识； 6）研究药房提供商业可用和研究新药的肿瘤药物研究服务。 CPSR目前为13位NCCC调查人员提供价值118,881美元的服务。 2007财年。NCCC成员使用此设施在达特茅斯的调查人员总数的76％，它们的使用占CPSR总使用量的87％。该核心的总退款为$ 130,161 在2007财年期间，总运营预算为397,951美元，需要$ 267,789的非电荷返还亚条件，该子发件源自NCCC CCSG的组合和对其他赞助的退款项目。该共享资源要求从NCCC CCSG的第一年的NCCC CCSG预算109,722美元这种竞争性更新（2008-09），代表与当年支持相当的水平，这将提供39％的非充电子条款需求，而大多数成本则通过退款和其他机构支持。该核心赠款预算和其他亚发项资料主要承保单个NCCC调查人员的一部分退款费用，并提供对该共享资源监督的行政支持。