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中文摘要
翻译
产品表征和操作核心,或"产品核心B",将是一个关键的和总体的 TCORS的一个组成部分,不断为中心的三个研究项目提供服务和信息, 描述新的和经过处理的烟草产品的毒性和相对危害。烟草 产品按照FDA CTP的使命优先考虑,以保障公众健康, 通过一些烟草控制的主要科学专家之间的批判性科学讨论, 担任中心外部和内部咨询委员会的成员。产品核心B 由经验丰富的烟草暴露科学家组成的领导层负责确定 最适合了解与目标产品相关的毒性的分析技术。一个 由多学科科学家组成的团队在监管环境中工作的经验丰富的领导者。博士 悉尼M.戈登,将促进核心之间的沟通,快速反应中心的CTP 要求,三个研究项目,以及内部和外部咨询委员会。他还将 执行这些小组制定的决策和政策,并监控时间表、里程碑, 以确保一个成功运作的核心。戈登博士支持开展这项工作, 一个经验丰富的合作者,一个项目控制专家,和一个合格的人类接触团队, 评估科学家,包括气溶胶物理学家和分析化学家。他的长期团队 开创了许多必要的分析技术,以进行产品特性的烟熏 和无烟烟草产品,并获得多个冗余设备,以处理快速 响应请求和大量需求。FDA CTP可用的其他产品核心B资源 包括高通量、连续监测和巴特尔开发新分析技术, 定量挥发性、半挥发性和重金属成分的水平,以及细菌多样性, 烟草所有产品核心B测量都将是客观的、可辩护的,并得到可靠的质量支持 保证/质量控制计划。
英文摘要
The Product Characterization and Manipulation Core, or "Product Core B," will be a critical and overarching component of the TCORS continuously serving and informing the three research projects in the Center by characterizing the toxicity and relative harm of new and manipulated tobacco products. The tobacco products are prioritized in accordance with FDA CTP's mission to safeguard the public health, accomplished via critical scientific discussion among some of tobacco control's leading scientific experts, who will be serving as members on the Center's external and internal advisory committees. Product Core B's leadership, composed of experienced tobacco exposure scientists, is responsible for identifying the analytical techniques most suitable to understand the toxicity associated with the products of interest. An experienced leader of teams made up of multidisciplinary scientists operating in regulatory environments. Dr. Sydney M. Gordon, will facilitate communication between the Core, rapid responses of the Center to CTP requests, the three Research Projects, and internal and external advisory committees. He will also implement the decisions and policies developed by these groups, and monitor timelines, milestones, and deliverables to ensure a successfully functioning Core. Dr. Gordon is supported in carrying out this work by an experienced collaborator, a project control specialist, and a team of qualified human exposure assessment scientists, including aerosol physicists and analytical chemists. His long-standing team has pioneered many of the analytical techniques necessary to conduct the product characterization of smoked and smokeless tobacco products and has access to multiple redundancies in equipment to handle rapid response requests and high volume demand. Additional Product Core B resources available to FDA CTP include high throughput, continuous monitoring, and novel Battelle-developed analytical techniques for quantifying levels of volatile, semi-volatile, and heavy metal components, as well as bacterial diversity in tobacco. All Product Core B measurements will be objective, defensible, and supported by a robust Quality Assurance/Quality Control program.
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Core D: Research Training and Education Plan
  • 批准号:
    9334811
  • 项目类别:
  • 资助金额:
    $45.41万
  • 财政年份:
    2017
  • 负责人:
    PAMELA I CLARK
  • 依托单位:
Project 2: Consumer Acceptability Testing of New & Manipulated Tobacco
  • 批准号:
    9334806
  • 项目类别:
  • 资助金额:
    $21.35万
  • 财政年份:
    2017
  • 负责人:
    PAMELA I CLARK
  • 依托单位:
Project 3: Exploring Tobacco Microbial Constituents and the Oral Microb
  • 批准号:
    9334807
  • 项目类别:
  • 资助金额:
    $54.9万
  • 财政年份:
    2017
  • 负责人:
    PAMELA I CLARK
  • 依托单位:
Project 3: Exploring Tobacco Microbial Constituents and the Oral Microb p215-251
  • 批准号:
    8590415
  • 项目类别:
  • 资助金额:
    $48.33万
  • 财政年份:
    2013
  • 负责人:
    PAMELA I CLARK
  • 依托单位:
海外基金