Clinical Pharmacology (CP)

临床药理学（CP）

• 批准号: 10311226
• 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
• 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/10311226
• 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; Tumor Tissue; Urine; cost; data modeling; design; detection method; epidemiology study; in vivo; liquid chromatography mass spectrometry; member; novel; operation; pharmacodynamic model; pharmacokinetics and pharmacodynamics; pre-clinical; preclinical study; programs; translational therapeutics; ultraviolet

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