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ABSTRACT - New Approach Methodologies (NAMs) are an emerging set of chemical safety assessment tools comprised 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.
A virtual symposium was held during the 2021 CORESTA 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 and research organizations shared insights on the status and available tools, strengths, limitations, and opportunities in application of NAMs using case examples from safety assessments of environmental chemicals and tobacco products.
The symposium, endorsed by the CORESTA In Vitro Tox Subgroup, Biomarker Subgroup, and NextG Tox Task Force, illustrated the 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.
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