Workshop Series to identify, discuss and develop recommendations for the optimal generation and use of in vitro assay data for tobacco product regulation.

研讨会系列旨在确定、讨论和制定最佳生成和使用烟草产品监管体外测定数据的建议。

• 批准号: 10720850
• 负责人: Rodger D Curren
• 金额: $ 5万
• 依托单位: INSTITUTE FOR IN VITRO SCIENCES, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-01 至 2024-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10720850
• 关键词: Workshop; Series; identify; discuss; develop

Project Summary/Abstract Research priorities for the Center for Tobacco Products (CTP) include “Evaluation of toxicity from exposures to complex mixtures of tobacco-related constituents in ENDS aerosol, waterpipe smoke, cigar smoke, and smokeless tobacco using toxicological assays such as in vivo, in silico, as well as in vitro models that are more physiologically relevant to humans.” Although CTP regulatory guidance documents include genotoxicity and other in vitro assays in the types of toxicity information required for submissions, there is no standardized guidance or regulatory approved methods for the evaluation of various tobacco products, including ENDS. Therefore, the Institute for In Vitro Sciences (IIVS), a 501(c)(3) nonprofit organization, has organized a Workshop Series to identify, discuss and develop recommendations for the best scientific/technical approaches for generating and interpreting in vitro assay data for comparing toxicity within and across tobacco product classes. Designed as true working meetings, expert stakeholders will discuss and develop recommendations that will then be published. The initial focus of the series (2018 – 2022) has been on the use of the regulatory genetic toxicology assays (Ames test, in vitro mammalian assays for cytogenetic damage and gene mutation) with various types of tobacco and nicotine products. Going forward we will finalize recommendations for the use of the genetic toxicology assays and transition to an emphasis on human in vitro models of potential target tissue, some of which can be utilized as disease models. These workshops provide a unique opportunity for multiple stakeholders to share their expertise and will provide published resources that regulatory agencies, academic laboratories, and industry may use as they address the public health issues related to the use of tobacco products. Some of workshop reports may serve as authoritative publications that can be referenced for optimal methodologies and data interpretation. So far, the workshops (1-7) have identified important issues for using in vitro assays for evaluating tobacco products and have focused on several of CTP’s high-priority topics. Multiple working groups have been established to collect background information, to hold discussions between workshops, and to develop recommendations that are discussed during the workshops. Multiple sets of recommendations have resulted from these workshops. Three manuscripts have been published, one is in press, and seven are in preparation. Final recommendations for using the Ames assay to compare within and between various tobacco and nicotine containing products will be addressed in Workshop 8 (February 2023). Workshop 9 (June 2023) will focus on: 1) oral tobacco and nicotine products (chemistry and in vitro methods), and 2) approaches for evaluating both general toxicity and disease- causing potential of tobacco products using human 3-D tissue models.

项目概要/摘要 烟草制品中心 (CTP) 的研究重点包括“评估接触烟草的毒性” ENDS 气溶胶、水烟烟雾、雪茄烟雾中与烟草相关成分的复杂混合物 无烟烟草使用毒理学测定，例如体内、计算机以及体外模型， 尽管 CTP 监管指导文件包括遗传毒性和 其他体外试验中所需提交的毒性信息类型，目前尚无标准化 用于评估各种烟草产品（包括 ENDS）的指南或监管批准的方法。 因此，501(c)(3) 非营利组织体外科学研究所 (IIVS) 组织了一次 研讨会系列旨在确定、讨论和制定最佳科学/技术建议 生成和解释体外测定数据以比较烟草内部和跨烟草毒性的方法 产品课程被设计为真正的工作会议，专家利益相关者将讨论和开发。 该系列（2018 年至 2022 年）的最初重点是使用。 监管遗传毒理学测定（艾姆斯试验、体外哺乳动物细胞遗传学损伤测定和 基因突变）与各种类型的烟草和尼古丁产品的未来我们将最终确定。 关于使用遗传毒理学测定和过渡到强调人体体外的建议 潜在靶组织模型，其中一些可以用作疾病模型。 为多个利益相关者提供独特的机会来分享他们的专业知识，并将提供已发布的资源 监管机构、学术实验室和工业界在解决公共卫生问题时可以使用 与烟草制品的使用有关的一些研讨会报告可以作为权威出版物。 到目前为止，研讨会（1-7）已经提供了最佳方法和数据解释的参考。 确定了使用体外测定评估烟草产品的重要问题，并重点关注 CTP 的几个高优先级主题已成立多个工作组来收集背景信息。 信息，在研讨会之间进行讨论，并制定讨论的建议 这些研讨会提出了多套建议。 手稿已出版，一份正在印刷，七份正在准备最终建议。 使用艾姆斯测定法来比较各种烟草和含尼古丁产品的内部和之间 第 8 次研讨会（2023 年 2 月）讨论的主题是：1) 口腔烟草和尼古丁。 产品（化学和体外方法），以及2）评估一般毒性和疾病的方法- 使用人体 3D 组织模型开发烟草产品的潜力。