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.

项目总结-产品评价和操作核心 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）中进行的研究和试点研究需要为周围的证据库提供信息， 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， 成瘾性和毒性。我们的中心专注于具有可信潜在危害的新型烟草产品 减少吸烟者或无烟烟草使用者。然而，数据差距很大， 关于关键产品特性和对非使用者的吸引力;鉴于其高流行率，这一点令人担忧 使用和最近的销售快速增长。PEMC将生成产品表征数据， 与P1-P4结果一致，将实现我们中心的目标：提供澄清 在既定的烟草制品使用中有意义地减少危害的途径，同时限制了新烟草制品的吸引力。 烟草产品的青少年和成年人从不吸烟。对烟草产品设计的深刻理解 特性，包括化学，物理和细菌特性，是该行业消费者的核心 响应模型。因此，PEMC在我们中心的综合主题“翻转 脚本”：使用行业的尼古丁剧本，以最大限度地提高公共健康，因为我们奋进产生 需要数据来推动监管政策，最大限度地提高公众健康，而不是行业销售。PEMC具体 目的是1）精确操纵EC液体中的三个尼古丁维度，以评估其对人体的影响 行为，主流排放和细胞毒性;和2）采用一系列物理化学分析 量化烟草产品中尼古丁尺寸、其他成分和污染物的方法，以及3） 有害和潜在有害的成分和其他有毒物质。PEMC将由教授领导。 Marielle Brinkman和Ahmad El Hellani博士，他们在操纵和描述 烟草制品为烟草监管科学中心和独立的烟草监管提供信息 赠款。OSU-TCORS PEMC提出了一套高度集成和多样化的理化分析方法， 能力，在操纵烟草产品方面的成功记录，以告知监管，以及强大的 强调通过强大的质量控制程序对所有测量进行鉴定。