Core B: Product Characterization and Manipulation Core p267-292

产品表征和操作核心，或“产品核心B”，将是一个关键和压倒一切的 TCORS的组成部分继续为中心的三个研究项目提供服务和信息 表征新的和经过处理的烟草产品的毒性和相对危害。烟草 根据FDA CTP保护公众健康的使命，对产品进行优先排序，完成 通过一些烟草控制的顶尖科学专家之间的关键科学讨论，他们将 担任中心外部和内部咨询委员会的成员。产品核心B的 领导层由经验丰富的烟草暴露科学家组成，负责确定 最适合于了解与感兴趣产品相关的毒性的分析技术。一个 由在监管环境中操作的多学科科学家组成的团队的经验丰富的领导者。Dr。 西德尼·M·戈登将促进核心之间的沟通，中心对CTP的快速反应 请求、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、里程碑和 确保核心成功运行的交付内容。戈登博士在开展这项工作方面得到了支持 经验丰富的合作者、项目控制专家和合格的人力资源团队 评估科学家，包括气溶胶物理学家和分析化学家。他的长期团队已经 开创了许多必要的分析技术，以进行烟熏产品的表征 和无烟烟草产品，并可利用设备中的多个冗余来处理快速 响应请求和高容量需求。FDA CTP可使用的其他产品核心B资源 包括高吞吐量、连续监测和由Battelle开发新的分析技术 量化挥发性、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的测量都将是客观的、可辩解的，并得到可靠质量的支持 保证/质量控制程序。

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.