Analytical Pharmacology Core

分析药理学核心

• 批准号: 10328527
• 负责人: TIMOTHY W SYNOLD
• 金额: $ 11.15万
• 依托单位: BECKMAN RESEARCH INSTITUTE/CITY OF HOPE
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-08-01 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10328527
• 关键词: 3-Dimensional; Advisory Committees; Antibodies; Antisense Oligonucleotides; Applications Grants; Biological; Biological Markers; Biological Products; Cancer Biology; Cancer Center Support Grant; Clinical; Clinical Investigator; Clinical Protocols; Clinical Trials; Collaborations; Complex; Consult; Consultations; Core Facility; Correlative Study; Coupled; Data; Data Analyses; Development; Drug Kinetics; Elements; Environment; Enzyme-Linked Immunosorbent Assay; Equipment; Experimental Designs; Faculty; Feedback; Fostering; Funding; Gene Expression; Guava Fruit; Hematology; High Pressure Liquid Chromatography; Human Resources; Immunoassay; Individual; Investigation; Label; Laboratory Study; Malignant Neoplasms; Manuscripts; Mass Fragmentography; Mass Spectrum Analysis; Medical Oncology; Metals; Modernization; Molecular; Molecular Analysis; Peer Review; Pharmaceutical Preparations; Pharmacodynamics; Pharmacology; Phase I Clinical Trials; Phase II Clinical Trials; Plasma; Population; Positioning Attribute; Postdoctoral Fellow; Preparation; Process; Protocols documentation; Publications; Reader; Reproducibility; Research; Research Design; Research Personnel; Research Project Grants; Resource Sharing; Sampling; Scientist; Services; Specimen; Specimen Handling; Students; Surveys; System; Teacher Professional Development; Techniques; Therapeutic; Training; Vaccines; Walking; Water; Writing; analytical method; assay development; base; cancer clinical trial; cell analyzer; design; digital; drug development; epidemiology study; graduate student; improved; instrument; instrumentation; mass spectrometer; member; novel; pharmacodynamic biomarker; pharmacokinetics and pharmacodynamics; pre-clinical; primary endpoint; professor; programs; small molecule; synthetic polymer Bioplex

Analytical Pharmacology Core Facility Shared Resource ABSTRACT The Analytical Pharmacology Core Facility (APCF) encourages and facilitates collaborative research between basic scientists and clinicians by providing comprehensive analytical and consultative services in a GLP-capable environment. The APCF assists with the design and implementation of pharmacokinetic, pharmacodynamic, and biomarker correlative studies for clinical and preclinical investigations of small molecules and biologic agents (e.g., antibodies, antisense oligonucleotides, vaccines, and cellular therapeutics). Primary services provided are: 1) quantitative assay development and sample analysis (LC-MS/MS, ICP-MS, GC/MS, HPLC, Luminex, ELISA, qPCR) of drugs, biomarkers, and related compounds; and 2) study design and expert analysis of pharmacokinetic and biomarker data. All major analytical equipment is consolidated into a contiguous suite of rooms in the Shapiro building. The most heavily utilized major equipment within the core are the LC-MS/MS instruments and the FLEXMAP 3D multiplex immunoassay platform. Mass spectrometry instrumentation includes a Micromass Quattro Ultima triple quad, a Waters Quattro Premier XE triple quad, an AB Sciex QTRAP 5500, an Agilent 6410, and a recently acquired Waters Xevo-TQXS. All systems provide state-of-the-art selectivity and sensitivity for detecting and quantifying analytes in complex biological matrices and are interfaced with HPLC front-end components. Additional key core equipment include an Agilent 8800 inductively-coupled plasma triple quadrupole mass spectrometer (ICP-MS) for determination of metals and metal-containing compounds and four complete HPLC systems. For analysis of biological agents, the Core has a FLEXMAP 3D Bioplex instrument for multiplex immunoassays, a Bio-Rad QX200 Droplet Digital PCR for absolute quantitation of gene expression, a FLUOstar OPTIMA multi-label plate reader for a wide range of high-throughput ELISA applications, and a Guava PCA-96 analytical cell analyzer. The core is directed by Dr. Timothy Synold, a Professor in the Department of Cancer Biology, with oversight by an interdisciplinary faculty Advisory Committee. Dr. Synold actively participates in most of the early drug development efforts within the Divisions of Hematology and Medical Oncology, which is reflected in the heavy usage by members of the DCT and HM Programs. User feedback is provided annually through user surveys. Since the last competitive renewal, the APCF contributed to 44 publications by CC members. Over the past five years, the APCF was used by a total of 74 unique investigators, including 56 CC members from all five Programs. Of the 56 CC members, 46 (82%) had peer-reviewed funding. During this period, 147 unique analytical methods were developed or re-initiated and 24,502 samples were analyzed. In addition, 4,632 clinical specimens were processed and 75 separate cancer clinical trials were supported by the core.

分析药理学核心设施共享资源 摘要 分析药理学核心设施（APCF）鼓励和促进合作研究， 基础科学家和临床医生通过提供全面的分析和咨询服务，在GLP能力 环境APCF协助设计和实施药代动力学、药效学和 用于小分子和生物制剂临床和临床前研究的生物标志物相关研究 (e.g.,抗体、反义寡核苷酸、疫苗和细胞治疗剂）。 提供的主要服务包括：1）定量分析开发和样品分析（LC-MS/MS，ICP-MS， 药物、生物标志物和相关化合物的GC/MS、HPLC、Luminex、ELISA、qPCR）;和2）研究设计和 药代动力学和生物标志物数据的专家分析。 所有主要的分析设备都集中在夏皮罗大楼的一个相连的房间里。最 核心内使用率很高的主要设备是LC-MS/MS仪器和FLEXMAP 3D多路复用器 免疫分析平台。质谱仪器包括Micromass Quattro Ultima三重四重质谱仪、 沃茨Quattro Premier XE三重四重、AB Sciex QTRAP 5500、Agilent 6410和最近收购的 沃茨Xevo-TQXS。所有系统都具有最先进的检测和定量选择性和灵敏度 分析物在复杂的生物基质和接口与HPLC前端组件。附加键芯 设备包括Agilent 8800电感耦合等离子体三重四极杆质谱仪（ICP-MS） 用于金属和含金属化合物的测定和四个完整的HPLC系统。用于分析 生物制剂，核心有一个FLEXMAP 3D Bioplex仪器的多重免疫测定，一个Bio-Rad 用于基因表达绝对定量的QX 200 Droplet Digital PCR，FLUOstar OPTIMA多标记板 一个用于广泛的高通量ELISA应用的阅读器，和一个Guava PCA-96分析细胞分析仪。 该核心由癌症生物学系教授Timothy Synold博士指导，并由 一个跨学科的教师咨询委员会Synold博士积极参与了大多数早期药物治疗， 血液学和内科肿瘤学部门内部的发展努力，这反映在沉重的 DCT和HM计划成员的使用。每年通过用户调查提供用户反馈。 自上次竞争性更新以来，APCF为CC成员的44篇出版物做出了贡献。过去五 2004年，APCF被74名独立研究者使用，其中包括来自所有五个项目的56名CC成员。 在56个协调委员会成员中，46个（82%）获得了同行评审的资金。在此期间，147种独特的分析方法 开发或重新启动，分析了24，502个样本。此外，还对4，632份临床标本进行了 核心小组支持了75项独立的癌症临床试验。