Analytical Pharmacology

分析药理学

• 批准号: 10409366
• 负责人: MICHELLE A RUDEK
• 金额: $ 21.62万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-05-07 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10409366
• 关键词: AIDS Malignancy Consortium; Adult; Amendment; Analytical Chemistry; Antineoplastic Agents; Applications Grants; Binding Proteins; Biological; Biological Assay; Biological Markers; Brain Neoplasms; Cancer Center Support Grant; Clinical; Clinical Pharmacology; Clinical Trials; Clinical trial protocol document; Comprehensive Cancer Center; Consultations; Coupled; Data Analyses; Dose; Drug Kinetics; Early Therapeutic-Clinical Trials Network; Ensure; Environment; Faculty; Floor; Funding; Grant; Human Resources; In Vitro; Ions; Laboratories; Lead; Letters; Liquid Chromatography; Liquid substance; Malignant Neoplasms; Manuscripts; Metabolic; Methods; Ohio; Oncology; Peer Review; Performance; Pharmacodynamics; Pharmacogenetics; Pharmacology; Pharmacology Shared Resource; Phenotype; Plasma; Plasma Proteins; Play; Protocols documentation; Publications; Reporting; Research; Research Design; Resource Sharing; Role; Sampling; Schedule; Services; Specimen; System; Toxic effect; Validation; Vision; analytical method; anticancer research; assay development; cost effective; design; detector; drug development; drug discovery; drug metabolism; experimental study; good laboratory practice; instrument; instrumentation; ion mobility; mass spectrometer; member; metabolic abnormality assessment; method development; pre-clinical; preclinical development; preclinical study; programs; protocol development; response; tool; translational pipeline; translational study

PROJECT SUMMARY/ABSTRACT The Sidney Kimmel Comprehensive Cancer Center (SKCCC) Analytical Pharmacology Shared Resource (APSR) has offered state-of-the-art and cost-effective analytical chemistry and clinical pharmacology services to Members continuously since its inception in 1985. The APSR provides instrumentation and facilities in a 1,750 ft2 laboratory on the first floor of the SKCCC Bunting-Blaustein Cancer Research Building. The specific aims of APSR are to: 1) provide expertise in clinical trial and preclinical study design, with a focus on critical pharmacological endpoints; 2) provide state-of-the-art, Good Laboratory Practice-quality, cost-effective services to quantitate anticancer drugs and metabolites or biomarkers in biological fluids; and 3) provide exposure-response analysis and interpretation, with the long-term vision of providing decision tools for drug development in both the preclinical and clinical settings. The APSR houses four ultra-performance liquid chromatography instruments with one UV/Vis detector, three triple-stage quadruple mass spectrometers, one QTrap system with ion trap capabilities for more intricate drug metabolism studies, and one ion mobility spectrometer. The APSR analyzes ~3,600 samples/year, develops ~15 new methods involving ~30 analytes per year and serves 29 faculty members across six of the CCSG Programs (plus nonprogrammatically aligned), with the majority of the users having peer-reviewed funding. The APSR remains a critical component across the translational spectrum, providing services in analytical method development (two manuscripts), drug discovery (three manuscripts), preclinical studies (16 manuscripts), clinical trials (18 manuscripts), exposure- response analyses (five manuscripts) and three other manuscripts. The APSR has participated in the submission of 57 cancer-focused grants over five years (across all CCSG Programs); played a major role in the successful applications for the Johns Hopkins Early Therapeutics Clinical Trials Network (UM1), AIDS Malignancy Consortium (UM1) and Chesapeake-Ohio Pharmacokinetics Core for the ETCTN (U24); and serves as a second laboratory for the Adult Brain Tumor Consortium (UM1). The requested CCSG funding will support personnel who provide consultative services related to assay development, protocol design and data interpretation, and ensure that instrumentation is suitably maintained and utilized efficiently. SKCCC Managed Shared Resource Reporting Period: January 1, 2020 to December 31, 2020

项目概要/摘要 Sidney Kimmel 综合癌症中心 (SKCCC) 分析药理学共享资源 (APSR) 提供最先进且具有成本效益的分析化学和临床药理学服务 自 1985 年成立以来，APSR 不断向会员提供仪器和设施 1,750 平方英尺的实验室位于 SKCCC Bunting-Blaustein 癌症研究大楼一楼。具体的 APSR 的目标是：1）提供临床试验和临床前研究设计方面的专业知识，重点关注关键问题 药理学终点； 2) 提供最先进的、良好的实验室实践质量、成本效益 定量生物体液中抗癌药物和代谢物或生物标志物的服务； 3) 提供 暴露-反应分析和解释，长期愿景是为药物提供决策工具 临床前和临床环境中的发展。 APSR 拥有四种超高性能液体 色谱仪器，配有一台紫外/可见检测器、三台三级四极质谱仪、一台 QTrap 系统具有离子阱功能，可用于更复杂的药物代谢研究，并具有一种离子淌度 光谱仪。 APSR 每年分析约 3,600 个样品，开发约 15 种新方法，涉及约 30 种分析物 每年为 6 个 CCSG 项目（加上非项目方式）的 29 名教员提供服务 一致），大多数用户都有同行评审的资金。 APSR 仍然是一个关键组成部分 跨越翻译领域，提供分析方法开发服务（两份手稿）、药物 发现（三篇稿件）、临床前研究（16篇稿件）、临床试验（18篇稿件）、暴露- 反应分析（五份手稿）和其他三份手稿。 APSR 已参加 五年内提交 57 项以癌症为重点的拨款（涵盖所有 CCSG 计划）；发挥了重要作用 约翰霍普金斯大学早期治疗临床试验网络（UM1）、艾滋病的成功申请 恶性肿瘤联盟 (UM1) 和 ETCTN (U24) 的切萨皮克-俄亥俄药代动力学核心；和 作为成人脑肿瘤联盟 (UM1) 的第二个实验室。所请求的 CCSG 资金将 支持人员提供与检测开发、方案设计和数据相关的咨询服务 解释，并确保仪器得到适当维护和有效利用。 SKCCC 管理共享资源 报告期间：2020年1月1日至2020年12月31日