Analytical Pharmacology

项目摘要/摘要 西德尼·基梅尔综合癌症中心(SKCCC)分析药理学共享资源 (APSR)提供最先进、最具成本效益的分析化学和临床药理学服务 自1985年成立以来，一直向会员提供服务。APSR提供了仪器和设施在 位于SKCCC Bunting-Blaustein癌症研究大楼一楼的1750平方英尺的实验室。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，重点是关键 药理学终端；2)提供最先进的、良好的实验室操作规范--高质量、高成本效益 对生物体液中的抗癌药物和代谢物或生物标志物进行定量的服务；以及3)提供 暴露-反应分析和解释，着眼于为药物提供决策工具 在临床前和临床环境中的发展。APSR搭载了四种超性能液体 配有一台UV/VIS检测器、三台三级四重质谱仪、一台 具有离子捕获能力的QTrap系统，用于更复杂的药物代谢研究，以及一个离子迁移率 分光计。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CCSG的六个项目中的29名教职员工提供服务(外加非编程方式 协调一致)，大多数用户都有同行审查的资金。APSR仍然是一个关键组件 跨翻译领域，提供分析方法开发(两份手稿)、药物 发现(3篇手稿)，临床前研究(16篇手稿)，临床试验(18篇手稿)，暴露- 答复分析(五份手稿)和其他三份手稿。APSR参与了 在五年内提交了57项以癌症为重点的赠款(在所有CCSG计划中)；在 约翰霍普金斯大学艾滋病早期治疗临床试验网络(UM1)的成功应用 ETCTN的恶性肿瘤联盟(UM1)和切萨皮克-俄亥俄州药代动力学核心(U24)；以及 作为成人脑瘤联盟(UM1)的第二个实验室。CCSG申请的资金将 提供与分析开发、方案设计和数据相关的咨询服务的支持人员 解释，并确保仪器得到适当的维护和有效利用。 SKCCC托管共享资源 报告期：2020年1月1日至2020年12月31日

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