Clinical Pharmacology (CP)

临床药理学（CP）

基本信息

批准号：
10554245
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
项目类别：
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/10554245
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 Translations Tumor Tissue Urine clinical translation cost data modeling design detection method epidemiology study in vivo liquid chromatography mass spectrometry member novel operation pharmacodynamic model pharmacokinetics and pharmacodynamics pharmacologic pre-clinical preclinical study programs ultraviolet

项目摘要

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) 共享资源已运行 24 年，为 Norris Cotton 提供支持癌症中心 (NCCC) 的研究人员设计、执行、数据分析和解释临床前（体内和离体）、临床和流行病学研究的药理学目标最低成本和可能的最高价值。主要的CP服务有四个领域： (1a) 新颖的开发分析物测定（当此类测定仅作为研究方法时）越来越多地使用液体- 色谱质谱 (LC-MS/MS) 或高效液相色谱 (HPLC) 紫外线和/或荧光检测方法； (1b) 分析物浓度测量的性能使用这些经过验证的生物分析方法在临床前和临床肿瘤学研究的生物样本中； (2a) 关于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 临床前和临床研究建模； (3) 生物样本（如细胞、肿瘤等）的中央处理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）；服务包括：样本记录、处理（包括处理外周血单核细胞）、必要时进行等分、储存和样品分配； (4) 癌症研究药学服务使用市售药物和研究性新药下的药物进行治疗性临床研究应用。 CP 由 Lionel D. Lewis 博士指导，他在临床表现方面拥有丰富的专业知识用于研究性肿瘤药物或药物/药物组合的早期临床研究的 PK 和 PD。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药理学家、一名研究助理兼实验室经理，具有不断扩展的生物分析和生物样本管理专业知识，以及具有肿瘤学和研究药物药学专业知识的研究药剂师。 2015 年 1 月 1 日至 2018 年 11 月 30 日，来自所有 4 个 NCCC 计划的 15 名 NCCC 会员使用了 CP 共享资源，其中 9 名是 3 个计划的现任成员（CPS [2]、CBT [6] 和 ICI [1]）。 NCCC 资助会员使用率 93% 总使用量（42 个项目），并且我们请求 CCSG 支持 CP 总运营预算的 78%。