Development and distribution of a certified reference cigarette suitable for rese

项目概要/摘要：自1968年以来，肯塔基州大学提供了 烟草制造商将香烟作为非临床研究目的的标准， 合同和政府实验室以及学术机构。肯塔基州大学 参考卷烟计划（UKRCP）致力于继续提供标准， 烟草产品研究，并与FDA合作开发必要的新产品， 法规和分析测试。该项目将生产和表征5000万，高- 代表美国混合香烟的质量参考香烟， 在一次生产运行中制造，具有经过认证的物理和化学特性， 允许能力验证、仪器校准、员工/学生培训、方法验证 和用于研究目的。设计、分析和批准原型的过程 研究香烟包括在内，以确保新的参考香烟符合规定的目标。 定义质量控制和样品检测参数， 将由制造商和独立的测试实验室进行， 产品物理参数和成分水平。 一个烟草产品分析和参考烟草产品的卓越中心将 与包括烟草中心在内的利益攸关方合作和协调研究 监管科学、产品测试实验室、烟草产品制造商和 烟草研究员该提案概述了对当前UKRCP的重大改进， 就运营效率而言，规划新的参考卷烟产品，建立 研究能力和新的服务，将有利于烟草研究界，包括 建立能力验证计划。将开发一个基于网络的界面， 安全传输和存储熟练程度计划的数据。作为一个学术机构 我们建议协调和管理烟草实验室之间的比较研究 参考产品和提供各种烟草参考产品作为服务的机制 对整个烟草研究界来说，这是对现有项目的改进。的 开发一种高质量的参考卷烟，并利用它来帮助建立 卓越将加强CTP发展烟草监管科学的努力， 为烟草产品研究和监管提供了急需的基本资源。

Project Summary/Abstract : Since 1968 the University of Kentucky has provided reference cigarettes as the standard for non-clinical investigational purposes by tobacco manufacturers, contract and government laboratories, and academic institutions. The University of Kentucky Reference Cigarette Program (UKRCP) is committed to continue providing standards for tobacco product research and to work with the FDA to develop new products as necessary for regulation and analytical testing. The project will produce and characterize 50 million, high- quality reference cigarettes representative of an American blended cigarette that are manufactured in one manufacturing run with certified physical and chemical characteristics to allow for proficiency testing, instrument calibration, employee/student training, method validation and for investigational purposes. A process for the design, analysis and approval of prototype research cigarettes is included to ensure the new reference cigarette meets the specified goals. Quality control and sample testing parameters are defined and substantial chemical analyses will be conducted by the manufacturer and independent testing labs to allow for certification of product physical parameters and constituent levels. A center of excellence in tobacco product analysis and reference tobacco products will be established to collaborate and coordinate studies with stakeholders, including Tobacco Centers for Regulatory Science, product testing laboratories, tobacco product manufacturers and tobacco researchers. This proposal outlines significant improvements to the current UKRCP in terms of operational efficiency, planning for new reference cigarette products, establishing research capability and new services that will benefit the tobacco research community including establishing a proficiency testing program. A web-based interface will be developed to allow for secure transmission and storage of data for the proficiency program. 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 a high-quality reference cigarette and using this to help establish the center of excellence will strengthen the CTP's effort to develop the science of tobacco regulation and provide a much needed basic resource for tobacco product research and regulation.