Cancer Pharmacokinetics and Pharmacodynamics Facility

癌症药代动力学和药效学设施

基本信息

批准号：
10024341
负责人：
Jan Hendrik Beumer
金额：
$ 22.05万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
1997
资助国家：
美国
起止时间：
1997-09-10 至 2025-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10024341
关键词：
Adopted Advisory Committees Antineoplastic Agents Award Biological Assay Budgets Cancer Center Cancer Center Support Grant Capital Cells Clinical Clinical Pharmacology Clinical Trials Clinical Trials Network Communities DNA Damage DNA Markers Data Data Analyses Development Drug Kinetics Ensure Equipment Exposure to Freezing Funding High Pressure Liquid Chromatography Human Resources Hybrids Injections Investigation Ions Joints Label Lead Liquid substance Malignant Neoplasms Measures Medicine Methodology Methods NCI Center for Cancer Research Nitrogen Outcome Peer Review Grants Pharmaceutical Preparations Pharmacodynamics Pharmacologic Substance Pharmacology Phase I Clinical Trials Phase II Clinical Trials Philosophy Population Power Sources Procedures Process Publications Quality Control Reader Reagent Research Research Design Research Personnel Resource Sharing Role Sampling Science Scientist Scintillation Counter Services Site Specialist Therapeutic Studies Training Translational Research Validation Water absorption drug development early phase clinical trial experience instrumentation meetings member mid-career faculty novel novel anticancer drug pharmacodynamic biomarker pharmacokinetics and pharmacodynamics pre-clinical professor programs sample collection skills small molecule

项目摘要

Abstract: Cancer Pharmacokinetics and Pharmacodynamics Facility (CPPF) The Hillman Cancer Center (HCC) Cancer Pharmacokinetics and Pharmacodynamics Facility (CPPF) is an important shared resource that supports science conducted by the HCC research programs and has a major impact on cancer drug development on a national level by providing state-of-the-art and comprehensive quantitative and qualitative bioanalytical support for preclinical and clinical cancer therapeutic studies. The activities of CPPF have earned national recognition for its exceptional service in developing and delivering PK and PD analyses of investigational agents. CPPF: (1) provides extensive pharmacology expertise to investigators by assisting in PK and PD study design and sample collection; (2) develops and provides quality-assured/quality-controlled quantitative and qualitative assay capabilities for rapid and efficient PK and PD bioanalyses; and (3) integrates PK/PD data through sophisticated data analyses. CPPF is located in two contiguous lab spaces with a shared office pod in the HCC Research Pavilion. Major equipment includes 3 Waters QuattroMicro LC-MS/MS, 2 SCIEX4000 LC-MS/MS (1 hybrid linear ion-trap), 2 HPLC-UV/FL/DAD, 1 HPLC-UV/RAD, 1 atomic absorption spectrometer, a LICOR Odyssey infra-red scanner, a Tecan Infinite Microplate Reader, and a Nexcelom Cellometer K2 Cell counter. Ancillary equipment includes -20 °C and -80 °C freezers, a nitrogen generator, and an uninterrupted power supply, as well as access to shared instrumentations including a liquid scintillation counter. CPPF is directed by Drs. Jan Beumer, Professor of Pharmaceutical Sciences and Medicine, and John Schmitz, Associate Professor of Medicine, and is overseen by an HCC Advisory Committee made up of HCC members. Dr. Beumer leads and Dr. Schmitz actively participates in the weekly Merrill Egorin Translational Research meeting, where HCC early drug development projects are discussed by an inter- disciplinary group of basic, translational, and clinical scientists, thereby ensuring appropriate consideration of CPPF’s role in these projects. During this funding period, CPPF analyzed samples for a total of 36 unique investigators and provided support for all 7 HCC research programs. During this funding period, CPPF developed 37 new assays, an average of 22 assays were used per year, and more than 30,000 samples were analyzed (excluding calibrators, quality controls or assay validation samples). CPPF supported 30 peer-reviewed grants and 70 publications, 30 of which were focused on clinical trials, and 19 of which focused on development of novel assay methodologies.

摘要：癌症药代动力学和药效学设施（CPPF）希尔曼癌症中心 (HCC) 癌症药代动力学和药效学设施 (CPPF) 是一个重要的共享资源，支持 HCC 研究项目开展的科学研究，并具有重大意义通过提供最先进和全面的技术对国家层面的癌症药物开发产生影响为临床前和临床癌症治疗研究提供定量和定性生物分析支持。 CPPF 的活动因其在开发和交付方面的卓越服务而赢得了国家认可研究药物的 PK 和 PD 分析。 CPPF：(1) 通过协助 PK 和 PD 研究设计，为研究人员提供广泛的药理学专业知识和样品收集；（2）开发并提供有质量保证/质量控制的定量和定性快速高效的 PK 和 PD 生物分析的测定能力；(3) 通过整合 PK/PD 数据；复杂的数据分析。 CPPF 位于两个相邻的实验室空间内，并在 HCC 主要研究馆内设有一个共用办公室。设备包括 3 台 Waters QuattroMicro LC-MS/MS、2 台 SCIEX4000 LC-MS/MS（1 台混合线性离子阱）、2 台 HPLC-UV/FL/DAD、1 台 HPLC-UV/RAD、1 台原子吸收光谱仪、1 台 LICOR Odyssey 红外扫描仪、包括 Tecan Infinite 酶标仪和 Nexcelom Cellometer K2 细胞计数器。 -20 °C 和 -80 °C 冷冻柜、氮气发生器、不间断电源以及访问共享仪器，包括液体闪烁计数器。 CPPF 由药物科学和医学教授 Jan Beumer 博士和 John 指导。 Schmitz 是医学副教授，由 HCC 咨询委员会监督，该委员会由以下人员组成： HCC 成员 Beumer 博士领导并 Schmitz 博士积极参与每周的 Merrill Egorin。转化研究会议，由内部人士讨论 HCC 早期药物开发项目由基础科学家、转化科学家和临床科学家组成的学科小组，从而确保适当的考虑 CPPF 在这些项目中的作用。在此资助期间，CPPF 分析了总共 36 名独特研究人员的样本，并提供了为所有 7 个 HCC 研究项目提供支持在此资助期间，CPPF 开发了 37 种新检测方法，每年平均进行 22 次检测，分析超过 30,000 个样本（不包括 CPPF 支持了 30 项同行评审的检测资助和 70 项出版物，其中 30 篇侧重于临床试验，其中 19 篇侧重于新型药物的开发测定方法学。