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State of the Science on Assessing Developmental Neurotoxicity Using New Approach Methods
Marlingen Biosci Inc, Ijamsville, MD USA..
US FDA, Human Foods Program, 5100 Campus Drive, College Pk, MD 20740 USA..
US Environm Protect Agcy, Ctr Computat Toxicol & Exposure, Off Res & Dev, Res Triangle Pk, NC USA..
Natl Ctr Adv Translat Sci, NIH, Bethesda, MD 20892 USA..
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2025 (English)In: Altex, ISSN 1868-596X, E-ISSN 1868-8551, Vol. 42, no 1, p. 121-144Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
ALTEX Edition , 2025. Vol. 42, no 1, p. 121-144
National Category
Pharmacology and Toxicology
Identifiers
URN: urn:nbn:se:uu:diva-551603DOI: 10.14573/altex.2410231ISI: 001416960200009PubMedID: 39675048Scopus ID: 2-s2.0-85215668052OAI: oai:DiVA.org:uu-551603DiVA, id: diva2:1941175
Funder
EU, Horizon 2020, 825759EU, Horizon 2020, 963845EU, Horizon Europe, 101057014German Research Foundation (DFG), 507269789NIH (National Institutes of Health), K99 ES031050NIH (National Institutes of Health), R35 ES031709Available from: 2025-02-27 Created: 2025-02-27 Last updated: 2025-02-27Bibliographically approved

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