Product Evaluation and Manipulation Core (PEMC)

产品评估和操作核心 (PEMC)

• 批准号: 10666073
• 负责人: AHMAD EL HELLANI
• 金额: $ 56.1万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-14 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10666073
• 关键词: Acute; Adolescent and Young Adult; Adult; Affect; Air; American; Behavior; Cardiovascular system; Cell Culture Techniques; Cells; Cessation of life; Characteristics; Chemicals; Cigarette; Cigarette Smoker; Complement; Data; Dimensions; Disease; Electronic cigarette; Epidemic; Epithelium; Equipment; Evaluation; Formulation; Goals; Grant; Harm Reduction; Health; High Prevalence; Human; Industry; Intervention Studies; Isomerism; Knowledge; Laboratories; Lebanon; Liquid substance; Lung; Mainstreaming; Malignant Neoplasms; Manuscripts; Marketing; Measurement; Modeling; Monitor; Nicotine; Ohio; Oral; Oral Tobacco; Output; Pathway interactions; Perception; Pilot Projects; Play; Policies; Prevalence; Property; Public Health; Publications; Qualifying; Quality Control; Records; Regimen; Regulation; Research; Research Design; Research Personnel; Resources; Role; Sales; Science; Standardization; Techniques; Testing; Tobacco; Tobacco Industry; Tobacco use; Toxic effect; Toxicology; United States Food and Drug Administration; Universities; Work; Youth; abuse liability; addiction; analytical method; cardiovascular endothelium; design; e-cigarette aerosols; electronic liquid; evidence base; experience; heated tobacco products; hookah; improved; in vitro testing; innovation; microbial; microbial composition; never smoker; novel; population health; programs; quality assurance; response; skills; smokeless tobacco user; timeline; tobacco products; tobacco regulation; tobacco regulatory science; toxicant; uptake; vaping

PROJECT SUMMARY – PRODUCT EVALUATION AND MANIPULATION CORE The goal of the Product Evaluation and Manipulation Core (PEMC) is to support and complement the human research conducted in the Projects (P1-P4) and pilot studies needed to inform the evidence base surrounding how the three nicotine dimensions (concentration, form, and isomer) affect tobacco product appeal, addictiveness, and toxicity. Our Center focuses on novel tobacco products that have a credible potential for harm reduction in established cigarette smokers or smokeless tobacco users. However, there are significant data gaps regarding key product characteristics and appeal to nonusers; which is concerning given their high prevalence of use and recent rapid increase in sales. The PEMC will generate product characterization data, which, in concert with P1-P4 results, will accomplish our Center's objective: provide the evidence needed to clarify a pathway for meaningful harm reduction in established tobacco product use, while limiting the appeal of novel tobacco products for youth and adult never smokers. A firm understanding of tobacco product design characteristics, including chemical, physical, and bacterial properties, is central to the Industry's Consumer Response Model. Therefore the PEMC plays a critical role in our Center's integrative theme “Flipping the Script”: Using the Industry's Nicotine Playbook to Maximize Public Health, as we endeavor to generate the data needed to fuel regulatory policies that maximize public health and not industry sales. The PEMC specific aims are to 1) Precisely manipulate the three nicotine dimensions in EC liquids to evaluate their effect on human behaviors, mainstream emissions, and cellular toxicity; and 2) Employ an array of physicochemical analytical methods to quantify nicotine dimensions, other ingredients, and contaminants, in tobacco products, and 3) harmful and potentially harmful constituents and other toxicants in their emissions. The PEMC will be led by Prof. Marielle Brinkman and Dr. Ahmad El Hellani, who have extensive experience manipulating and characterizing tobacco products to inform tobacco regulation in both Tobacco Regulatory Science Center and standalone grants. The OSU-TCORS PEMC proposes a highly integrated and diverse set of physicochemical analytical capabilities, a successful track record in the manipulation of tobacco products to inform regulation, and a strong emphasis on qualifying all measurements with a robust quality control program.

项目摘要——产品评估和操控核心 产品评估和操作核心 (PEMC) 的目标是支持和补充人类 在项目（P1-P4）中进行的研究以及为围绕相关证据基础提供信息所需的试点研究 尼古丁的三个维度（浓度、形式和异构体）如何影响烟草产品的吸引力， 我们的中心专注于具有可信潜在危害的新型烟草产品。 吸烟者或无烟烟草使用者的减少 然而，存在显着的数据差距。 关于关键产品特征和对非​​使用者的吸引力；鉴于其高普及率，这一点令人担忧； PEMC 将生成产品特征数据，这些数据在使用和近期销售快速增长的情况下。 与 P1-P4 结果相一致，将实现我们中心的目标：提供澄清问题所需的证据 有效减少既定烟草产品使用危害的途径，同时限制新颖的吸引力 面向从不吸烟的青少年和成人的烟草产品 对烟草产品设计有深刻的理解。 特征，包括化学、物理和细菌特性，是行业消费者的核心 因此，PEMC 在我们中心的综合主题“翻转”中发挥着至关重要的作用。 剧本”：利用行业的尼古丁手册最大限度地提高公众健康，我们努力创造 推动监管政策所需的数据，以最大限度地提高公众健康而不是特定于 PEMC 的行业销售。 目标是 1) 精确控制 EC 液体中的三个尼古丁维度，以评估其对人体的影响 2) 采用一系列物理化学分析 量化烟草产品中尼古丁含量、其他成分和污染物的方法，以及 3) PEMC 将由教授领导。 Marielle Brinkman 和 Ahmad El Hellani 博士在操控和表征方面拥有丰富的经验 烟草制品为烟草监管科学中心和独立机构的烟草监管提供信息 OSU-TCORS PEMC 提出了一套高度集成且多样化的物理化学分析方法。 能力、在烟草产品操纵方面为监管提供信息的成功记录以及强大的 强调通过强大的质量控制程序来验证所有测量结果。