Models For Tobacco Product Evaluation

描述（由申请人提供）：2009年，国会颁布了《家庭吸烟预防和烟草控制法》（FSPTCA），赋予食品和药物管理局（FDA）对烟草产品的监管权。根据这项法律，FDA必须评估新的和改良的烟草产品对人口的影响。然而，对评估这些产品应采用的措施和方法的了解有限。现在需要的是监管机构可以用来提前预测消费者可能如何反应的可靠和有效的措施和方法（即，使用导致接触）新的和改性的烟草产品。P01建立在我们之前的NCI合同[N 01 PC644202]的基础上，该合同提出了评估烟草产品的综合框架。本P01试图通过进行一系列相关研究来测试该框架的要素，这些研究旨在评估新的口服烟草产品的潜在摄入和依赖性以及当前吸烟者的有毒物质暴露。到目前为止，还没有进行系统和全面的研究来验证烟草产品评价的方法和措施。具体而言，项目1和项目2将评价评估烟草制品在动物和人类中的相对滥用倾向的方法和措施。项目3旨在了解和评估消费者对烟草制品看法的各个方面，项目4在临床试验的背景下评估烟草制品的使用及其对有毒物质暴露的影响。除了这些项目外，我们还有一个行政核心（核心A），负责支持赠款的管理，促进合作，确保我们科学的质量和及时性，整合项目的结果，并将我们的研究成果转化为潜在的政策; a烟草成分和生物标志物核心（核心B）该机构将负责提供成分分析，分析我们的样本中暴露和影响的致癌物生物标志物，并建立一个生物储存库; a生物统计学和信息学核心（核心C），负责数据库开发和管理、每个项目的统计分析以及协调各项目的数据分析。在P01结束时，我们将提供一系列方法和措施的可靠性和有效性的证据，这些方法和措施可用于预测消费者可能如何使用和滥用新的和改良的烟草产品。这项研究的结果将直接影响FDA和世界各地其他监管机构可能适用于评估新的和改良的烟草产品的危害减少潜力的方法和措施。此外，由于研究的综合性，P01将帮助我们了解产品特性、产品滥用倾向和消费者对产品的感知以及调节影响（即，性别、年龄、种族/民族）影响摄取和使用以及由此产生的毒物暴露。

DESCRIPTION (provided by applicant): In 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act (FSPTCA) which gave the Food and Drug Administration (FDA) regulatory authority over tobacco products. Under this law the FDA is required to evaluate new and modified tobacco products for their effects on a population wide-basis. Yet, there is limited knowledge on the measures and methods that should be used to evaluate these products. What is needed now are reliable and valid measures and methods that regulators can use to predict in advance how consumers are likely to respond (i.e., use leading to exposure) to new and modified tobacco products. This P01 builds on our previous NCI contract [N01PC644202], which proposed a comprehensive framework for evaluating tobacco products. This P01 attempts to test elements of that framework by conducting a series of interrelated studies designed to assess the potential uptake and dependence of a new oral tobacco product and resulting toxicant exposure in current cigarette smokers. To date, no systematic and comprehensive studies have been conducted to validate methods and measures for tobacco product evaluation. Specifically, Projects 1 and 2 will evaluate methods and measures to assess the relative abuse liability of tobacco products in animals and in humans. Project 3 seeks to understand and assess various aspects of consumer perception of tobacco products, and Project 4 assesses tobacco product use and its effects on exposure to toxicants in the context of a clinical trial. In addition to these Projects, we have an Administrative Core (Core A ) responsible for supporting the administration of the grant, facilitating collaboration, assuring th quality and timeliness of our science, integrating the results from the Projects and translating our research findings into potential policies; a Tobacco Constituent and Biomarker Core (Core B) that will be responsible for providing constituent analysis and analyzing our samples for carcinogen biomarkers of exposure and effect, and establishing a biorepository; a Biostatistics and Informatics Core (Core C) responsible for database development and management, statistical analysis for each of the projects, and coordinating data analysis across projects. At the conclusion of this P01 we will have produced evidence on the reliability and validity of an array of methods and measures that can be applied to predict how consumers are likely to use and abuse new and modified tobacco products. The findings from this study should directly influence the kinds of methods and measures that FDA and other regulatory groups around the world might apply to evaluating harm reduction potential of new and modified tobacco products. Furthermore, because of the integrative nature of the studies, this P01 will help us understand how product characteristics, product abuse liability and consumer perception of a product and moderating influences (i.e., sex, age, race/ethnicity) affects uptake and use and resulting toxicant exposure.