Debad Susan J, Aungst Jason, Carstens Kelly, Ferrer Marc, Fitzpatrick Suzanne, Fritsche Ellen, Geng Yijie, Hartung Thomas, Hogberg Helena T, Li Rong, Mangas Iris, Marty Sue, Musser Steven, Perron Monique, Rattan Saniya, Rüegg Joëlle, Sachana Magdalini, Schenke Maren, Shafer Timothy J, Smirnova Lena, Talpos John, Tanguay Robyn L, Terron Andrea, Bandele Omari
SJD Consulting LLC, Ijamsville, MD, USA.
US Food and Drug Administration, Human Foods Program, College Park, MD, USA.
ALTEX. 2025;42(1):121-144. doi: 10.14573/altex.2410231. Epub 2024 Dec 9.
The workshop titled State of the Science on Assessing Developmental Neurotoxicity Using New Approach Methods was co-organized by University of Maryland’s Joint Institute for Food Safety and Applied Nutrition (JIFSAN) and the U.S. Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN; now called the Human Foods Program), and was hosted by FDA in College Park, MD on November 14-15, 2023. This event convened experts from international organizations, governmental agencies, industry, and academia to explore the transition from traditional in vivo tests to innovative new approach methods (NAMs) in developmental neurotoxicity (DNT) testing. The discussions emphasized the heightened vulnerability of the developing human brain to toxic exposures and the potential of NAMs to provide more ethical, economical, and scientifically robust alternatives to traditional testing. Various NAMs for DNT were discussed, including in silico, in chemico, in vitro, non-mammalian whole organisms, and novel mammalian approaches. In addition to progress in the field, the workshop discussed ongoing challenges such as expectations to perfectly replicate the complex biology of human neurodevelopment and integration of DNT NAMs into regulatory frameworks. Presentations and panel discussions provided a comprehensive overview of the state of the science, assessed the capabilities and limitations of current DNT NAMs, and outlined critical next steps in advancing the field of DNT testing.
题为“利用新方法评估发育神经毒性的科学现状”的研讨会由马里兰大学食品安全与应用营养联合研究所（JIFSAN）和美国食品药品监督管理局（FDA）食品安全与应用营养中心（CFSAN；现称为人类食品项目）共同组织，并于2023年11月14日至15日由FDA在马里兰州大学公园市主办。该活动召集了来自国际组织、政府机构、行业和学术界的专家，探讨在发育神经毒性（DNT）测试中从传统体内试验向创新新方法（NAMs）的转变。讨论强调了发育中的人类大脑对有毒暴露的高度易感性，以及NAMs为传统测试提供更符合伦理、更经济且科学上更可靠替代方法的潜力。会上讨论了各种用于DNT的NAMs，包括计算机模拟、化学分析、体外、非哺乳动物全生物以及新型哺乳动物方法。除了该领域的进展外，研讨会还讨论了当前面临的挑战，如期望完美复制人类神经发育的复杂生物学过程以及将DNT NAMs整合到监管框架中。专题报告和小组讨论全面概述了科学现状，评估了当前DNT NAMs的能力和局限性，并概述了推进DNT测试领域的关键下一步措施。
