Analytical Pharmacology

项目总结/摘要 Sidney Kimmel综合癌症中心（SKCCC）分析药理学共享资源 （APSR）提供了最先进和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，不断向会员国提供服务。APSR提供仪器和设施， 位于SKCCC Bunting-Blaustein癌症研究大楼一楼的1，750平方英尺实验室。具体 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，重点是关键的 药理学终点; 2）提供最先进的药物非临床研究质量管理规范质量，具有成本效益 对生物流体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 确定-反应分析和解释，具有为药物提供决策工具的长期愿景 在临床前和临床环境中的发展。APSR拥有四种超性能液体 一台紫外/维斯检测器、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， 光谱仪APSR每年分析约3，600个样品，开发了约15种新方法，涉及约30种分析物 每年为29名教师提供六个CCSG计划（加上非编程 大多数用户都有经过同行审查的资金。APSR仍然是一个重要组成部分， 跨翻译范围，提供分析方法开发服务（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- 回应分析（五份手稿）和其他三份手稿。APSR参加了 在五年内提交了57份以癌症为重点的赠款（在所有CCSG计划中）;在以下方面发挥了重要作用： 约翰霍普金斯早期治疗药物临床试验网络（UM 1）的成功申请，艾滋病 ETCTN（U24）的美国药代动力学联盟（UM 1）和Chesapeake-Ohio药代动力学核心;以及 作为成人脑肿瘤联盟（UM 1）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