新方法方法(NAM)是新兴的化学安全评估工具,由体外和计算机(计算)方法组成,旨在减少,精炼,或取代(3R)传统上用于风险评估的各种体内动物测试方法。在采用NAM进行人类健康和环境毒性评估方面取得了重大进展。然而,需要进一步努力扩大其发展及其在监管决策中的使用。在2021年烟草科学研究合作中心(CORESTA)烟雾科学和产品技术(SSPT)会议(题为“推进减少烟草危害的新替代方法”)期间举行了一次虚拟研讨会,目的是介绍NAMs在潜在降低风险(PRR)烟草产品评估中的概念和潜在应用。在座谈会上,监管机构的专家,研究机构,和非政府组织分享了对现有工具状况的见解,优势,局限性,以及使用化学品和烟草制品安全评估中的案例实例应用NAM的机会。在提供NAM背景和应用的七个演示之后,举行了一次讨论,主持人和听众讨论了扩大烟草产品NAM毒理学应用的前景。研讨会,由CORESTA体外毒性亚组认可,生物标志物亚组,和NextGTox特别工作组,说明了科学界和利益相关者在支持烟草监管科学方面的共同点和兴趣。本文总结了研讨会的重点。
New approach methodologies (NAMs) are emerging chemical safety assessment tools consisting of in vitro and in silico (computational) methodologies intended to reduce, refine, or replace (3R) various in vivo animal testing methods traditionally used for risk assessment. Significant progress has been made toward the adoption of NAMs for human health and environmental toxicity assessment. However, additional efforts are needed to expand their development and their use in regulatory decision making. A virtual symposium was held during the 2021 Cooperation Centre for Scientific Research Relative to Tobacco (CORESTA) Smoke Science and Product Technology (SSPT) conference (titled \"Advancing New Alternative Methods for Tobacco Harm Reduction\"), with the goals of introducing the concepts and potential application of NAMs in the evaluation of potentially reduced-risk (PRR) tobacco products. At the symposium, experts from regulatory agencies, research organizations, and NGOs shared insights on the status of available tools, strengths, limitations, and opportunities in the application of NAMs using case examples from safety assessments of chemicals and tobacco products. Following seven presentations providing background and application of NAMs, a discussion was held where the presenters and audience discussed the outlook for extending the NAMs toxicological applications for tobacco products. The symposium, endorsed by the CORESTA In Vitro Tox Subgroup, Biomarker Subgroup, and NextG Tox Task Force, illustrated common ground and interest in science-based engagement across the scientific community and stakeholders in support of tobacco regulatory science. Highlights of the symposium are summarized in this paper.