Laboratory Core

实验室核心

• 批准号: 10666241
• 负责人: TORE EID
• 金额: $ 45.47万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-30 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10666241
• 关键词: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol; Acetals; Animals; Biological; Biological Assay; Biological Markers; Biological Specimen Banks; Chemicals; Collaborations; Consultations; Cotinine; Custom; Data; Databases; Dose; Equipment; Experimental Designs; Exposure to; Feedback; Flavoring; Goals; Human Resources; Knowledge; Laboratories; Marketing; Measures; Menthol; Methodology; Nicotine; Nicotine Dependence; Outcome; Outcome Study; Participant; Pilot Projects; Productivity; Publications; Quality Control; Reaction; Reproducibility; Research; Research Personnel; Resource Sharing; Resources; Rest; Risk; Sampling; Sampling Studies; Services; Site; Source; Sweetening Agents; Technology; Time; Tobacco Dependence; Tobacco use; Toxic effect; Toxicology; addiction; biobank; cost; data sharing; design; electronic liquid; enantiomer; experience; flexibility; interest; menthol glucuronide; novel; reduce tobacco use; repository; success; tobacco products; vapor; 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol; Acetals; Animals; Biological; Biological Assay; Biological Markers; Biological Specimen Banks; Chemicals; Collaborations; Consultations; Cotinine; Custom; Data; Databases; Dose; Equipment; Experimental Designs; Exposure to; Feedback; Flavoring; Goals; Human Resources; Knowledge; Laboratories; Marketing; Measures; Menthol; Methodology; Nicotine; Nicotine Dependence; Outcome; Outcome Study; Participant; Pilot Projects; Productivity; Publications; Quality Control; Reaction; Reproducibility; Research; Research Personnel; Resource Sharing; Resources; Rest; Risk; Sampling; Sampling Studies; Services; Site; Source; Sweetening Agents; Technology; Time; Tobacco Dependence; Tobacco use; Toxic effect; Toxicology; addiction; biobank; cost; data sharing; design; electronic liquid; enantiomer; experience; flexibility; interest; menthol glucuronide; novel; reduce tobacco use; repository; success; tobacco products; vapor

ABSTRACT – LABORATORY CORE The YCSTP’s goal is to reduce tobacco use and addiction. By understanding better how tobacco product constituents such as coolants, flavorants, sweeteners, nicotine source (natural vs. synthetic) and nicotine enantiomer (S- vs. R-) ratio influence appeal, we aim to inform the FDA about the risk of nicotine addiction and harm. Optimal interpretation of the study outcomes requires that key chemical components are accurately quantified in tobacco products and in biological samples from the study participants. The main objective of the Laboratory Core is to provide accurate, reproducible, and timely characterization and quantification of such components in support of the projects and pilots of the Center, as well as to create custom e-liquids when necessary. The core will attain its objective by pursuing five specific aims. (1) To identify and accurately quantify chemicals in tobacco products and in vapors produced from them, such as nicotine (including R- and S- enantiomers), synthetic coolants and menthol, flavorants, sweeteners, and other compounds of interest. (2) To generate objective and quantitative estimates of exposure to, and harm from, tobacco products by measuring the following biomarkers in biological samples: nicotine, cotinine, 3-hydroxy cotinine, total nicotine equivalents, nicotelline, menthol glucuronide, and NNAL (4-(methylnitrosamino)-1-(3- pyridyl)-1-butanol). (3) To maintain a database of tobacco product constituents, such as flavorants, coolants, and sweeteners. (4) To create custom e-liquids for ongoing studies when commercial products are not available due to market changes. (5) To maintain a repository of biological samples obtained from the study participants. The core will also be able to set up other assays, as mandated by the evolving needs of the center. Over the past 9 years, this core has significantly advanced knowledge about tobacco product constituents, including novel ones, and particularly how these constituents contribute to addiction and harm. The core will be successful because: (a) many of the chemical assays necessary for aims 1 and 2 are validated and ready for immediate use, (b) the core has an extensive track record of detecting novel tobacco product constituents of concern, (c) the core has the necessary expertise, facilities and equipment to set up new assays in a timely fashion, (d) the database (aim 3) and biorepository (aim 5) are already in place and can readily be expanded to accommodate the data and samples obtained from the new projects, and (e) the core has experience in creating custom e-liquids (aim 4). By providing these services reliably to the YCSTP, the Laboratory Core will contribute critically toward the success of YCSTP’s TCORS 3.0 projects, which will ultimately aid in informing the FDA on the risk of nicotine addiction in new products and constituents.

摘要 - 实验室核心 YCSTP的目标是减少烟草使用和成瘾。通过更好地了解烟草产品 构成冷却剂，味道，甜味剂，尼古丁来源（自然与合成）和尼古丁 对映异构体（s- vs. r-）影响外观，我们旨在告知FDA尼古丁成瘾的风险和 伤害。对研究结果的最佳解释要求关键的化学成分准确 在研究参与者的烟草产品和生物样品中进行了量化。主要目标 实验室核心是提供准确，可重复和及时的表征，并 量化此类组件以支持中心的项目和飞行员，以及 必要时创建自定义的电子液体。核心将通过追求五个特定目标来实现其目标。 （1） 识别并准确量化烟草产品和从中产生的蒸气中的化学物质，例如 尼古丁（包括r-和s-inantiomers），合成冷却剂和精神中半醇，口味，甜味剂和其他 感兴趣的化合物。 （2）产生对暴露和损害的客观和定量估计， 通过测量生物样品中的以下生物标志物：尼古丁，可替宁，3-羟基 可替宁，总尼古丁等效因素，烟碱，精神卢苏醛酸和nnal（4-（甲基硝基氨基氨基）-1-（3-）（3-） 吡啶基）-1-丁醇）。 （3）维护烟草产品结构的数据库，例如风味，冷却剂， 和甜味剂。 （4）在商业产品不在时创建用于正在进行研究的自定义电子液体 由于市场变化而可用。 （5）维持从研究中获得的生物样品的存储库 参与者。核心也将能够按照不断发展的需求来设置其他测定 中心。在过去的9年中，该核心对烟草产品具有很大的高级知识 组成部分，包括新颖的组成部分，尤其是这些组成部分如何促进成瘾和 伤害。核心将成功，因为：（a）目标1和2的许多化学测定是 经过验证并准备立即使用，（b）核心具有检测新型烟草的广泛记录 关注的产品构成，（c）核心具有建立必要的专业知识，设施和设备 以及时的方式进行新测定，（d）数据库（AIM 3）和生物座席（AIM 5）已经到位，并且可以 容易扩展以适应从新项目获得的数据和样本，（e）核心 具有创建自定义电子液体的经验（AIM 4）。通过可靠地向YCSTP提供这些服务， 实验室核心将为YCSTP的TCORS 3.0项目的成功做出重大贡献，该项目将 最终有助于向FDA告知新产品和构成中尼古丁成瘾的风险。