Smokeless Tobacco Reference Product Development, Distribution and Research

项目摘要/摘要：自1968年以来，肯塔基大学一直提供参考 作为非临床标准的烟草产品(包括最新的1R6F参考香烟) 烟草制造商、合同实验室和政府实验室的调查目的，以及 学术机构。肯塔基大学烟草参考产品中心 (CTRP)致力于提供烟草产品研究的认证标准，并与 FDA根据需要开发新的认证参考产品。该项目将生产和生产 描述代表散叶咀嚼烟草的无烟烟草参考产品的特征， 湿润的鼻烟，还有凹陷的鼻子。这些新的认证参考产品将在 每个生产运行一次，以确保产品一致性，并将具有经过认证的物理和 允许熟练测试、仪器校准、员工/学生使用的化学特性 培训，以及用于方法验证和调查目的。一个设计的过程， 包括分析和审批，以确保来自利益相关者的投入，并确保新的参考 无烟烟草产品符合规定的目标。质量控制和样品检测 定义了参数，并进行了大量的化学分析，以便 产品特性和组成级别的认证。 CTRP将推进与利益攸关方合作和协调研究的努力，包括 烟草管制科学中心、商业产品检测实验室、烟草产品 制造商和学术研究人员。该提案概述了对以下方面的重大改进 目前无烟烟草参考产品在产品设计和认证方面，产品 分销，产品储存，规划新的参考烟草产品，建立研究 并提供有益于烟草研究界的新服务。一张网- 用于订购参考烟草产品和用于安全传输的基于接口 协作数据存储正在开发中，并将得到增强，以包括无烟区 参考产品。作为一家学术机构，我们建议协调和管理国际 烟草参比产品的实验室比较研究和提供各种 烟草参考产品作为对整个烟草研究社区的服务是一种 对当前计划的改进。优质无烟烟叶的开发 参考产品并通过CTRP提供这些产品将加强食品和药物管理局的努力，以 发展烟草监管科学为烟草生产提供必要资源 研究和监管。

Project Summary/Abstract: Since 1968 the University of Kentucky has provided reference tobacco products (including the most recent 1R6F reference cigarette) as standards for non-clinical investigational purposes by tobacco manufacturers, contract and government laboratories, and academic institutions. The University of Kentucky, Center for Tobacco Reference Products (CTRP) is committed to supply certified standards for tobacco product research and to work with the FDA to develop new certified reference products as necessary. This project will produce and characterize smokeless tobacco reference products representative of loose leaf chewing tobacco, moist snuff, and pouched snus. These new certified reference products will be manufactured in one manufacturing run each, to ensure product uniformity, and will have certified physical and chemical characteristics to allow for proficiency testing, instrument calibration, employee/student training, and for method validation and investigational purposes. A process for the design, analysis, and approval is included to ensure input from stakeholders and that the new reference smokeless tobacco products meet the specified goals. Quality control and sample testing parameters are defined and substantial chemical analyses will be conducted to allow for certification of product characteristics and constituent levels. The CTRP will advance efforts to collaborate and coordinate studies with stakeholders, including Tobacco Centers for Regulatory Science, commercial product testing laboratories, tobacco product manufacturers, and academic researchers. This proposal outlines significant improvements to current smokeless tobacco reference products in terms of product design and certification, product distribution, product storage, planning for new reference tobacco products, establishing research capability and providing new services that will benefit the tobacco research community. A web- based interface for ordering reference tobacco products and for the secure transmission and storage of collaborative data is under development and will be enhanced to include the smokeless reference products. As an academic institution our proposal to coordinate and administer inter- laboratory comparison studies on tobacco reference products and mechanisms to provide various tobacco reference products as a service to the entire tobacco research community is an improvement over current programs. The development of high-quality smokeless tobacco reference products and providing those through the CTRP will strengthen the FDAs effort to develop the science of tobacco regulation and provide a necessary resource for tobacco product research and regulation.