Development and distribution of a certified reference cigarette suitable for rese

适合研究的认证参考卷烟的开发和销售

• 批准号: 8770265
• 负责人: Orlando Chambers
• 金额: $ 515.37万
• 依托单位: UNIVERSITY OF KENTUCKY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-01 至 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8770265
• 关键词: Development; distribution; certified; reference; cigarette

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.

项目概要/摘要：自 1968 年以来肯塔基大学提供了参考 卷烟作为烟草制造商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 监管和分析测试。该项目将生产和表征 5000 万个高 代表美国混合香烟的质量参考香烟是 在一次生产过程中制造，具有经过认证的物理和化学特性， 允许能力测试、仪器校准、员工/学生培训、方法验证 并用于研究目的。原型设计、分析和批准的流程 纳入研究香烟是为了确保新的参考香烟达到指定的目标。 定义质量控制和样品测试参数并进行大量化学分析 将由制造商和独立测试实验室进行，以允许认证 产品物理参数和成分含量。 烟草产品分析和参考烟草产品卓越中心将 成立的目的是与包括烟草中心在内的利益相关者合作和协调研究 适用于监管科学、产品测试实验室、烟草产品制造商和 烟草研究人员。该提案概述了对当前 UKRCP 的重大改进 运营效率方面，规划新的参考卷烟产品，建立 研究能力和新服务将使烟草研究界受益，包括 建立能力验证计划。将开发一个基于网络的界面，以允许 熟练程度计划数据的安全传输和存储。作为一个学术机构 我们关于协调和管理烟草实验室间比较研究的建议 参考产品和提供各种烟草参考产品即服务的机制 对于整个烟草研究界来说，这是对当前计划的改进。这 开发高质量的参考卷烟并利用它来帮助建立卷烟中心 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急需的基础资源。