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: 9039991
• 负责人: Orlando Chambers
• 金额: $ 70万
• 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/9039991
• 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.

项目摘要/摘要：自1968年以来，肯塔基大学提供了参考 香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 参考香烟计划（UKRCP）致力于继续提供标准 烟草产品研究并与FDA合作以开发新产品 调节和分析测试。该项目将生产并描述5000万个高级 代表美国混合香烟的质量参考香烟 在一项制造业中制造，具有认证的物理和化学特性 允许熟练测试，仪器校准，员工/学生培训，方法验证 并出于研究目的。原型设计，分析和批准的过程 包括研究香烟，以确保新的参考香烟达到指定目标。 定义了质量控制和样品测试参数并进行了实质性化学分析 制造商和独立测试实验室将进行 产品物理参数和组成级别。 烟草产品分析和参考烟草产品的卓越中心将是 建立以与利益相关者（包括烟草中心）合作和协调研究 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。该提案概述了当前的ukrcp的重大改进 运营效率条款，计划新参考香烟产品，建立 研究能力和新服务将使烟草研究社区受益 建立能力测试计划。将开发基于网络的接口以允许 安全传输和存储数据的能力计划。作为学术机构 我们关于烟草协调和管理实验室间比较研究的建议 参考产品和机制提供各种烟草参考产品作为服务 对于整个烟草研究界来说，是对当前计划的改进。这 开发高质量的参考香烟，并使用它来帮助建立中心 卓越将加强CTP发展烟草监管科学的努力和 为烟草产品研究和法规提供急需的基本资源。