03806nas a2200493   4500000000100000000000100001008004100002260001500043653000800058653004900066653003500115653002000150653002600170100001900196700001700215700001900232700001600251700002400267700001900291700001500310700001900325700002200344700001200366700001600378700001400394700001800408700001900426700001800445700001900463700002200482700001800504700002200522700001800544700001600562700002100578700001800599700001800617245009300635856006000728300001200788490000700800520249100807022001403298       2025                            d  c2025-01-1410a3Rs10aIn vitro developmental neurotoxicity testing10aalternatives to animal testing10ain vitro models10aRegulatory toxicology1 aSusan J. Debad1 aJason Aungst1 aKelly Carstens1 aMarc Ferrer1 aSuzanne Fitzpatrick1 aEllen Fritsche1 aYijie Geng1 aThomas Hartung1 aHelena T. Hogberg1 aRong Li1 aIris Mangas1 aSue Marty1 aSteven Musser1 aMonique Perron1 aSaniya Rattan1 aJoëlle Rüegg1 aMagdalini Sachana1 aMaren Schenke1 aTimothy J. Shafer1 aLena Smirnova1 aJohn Talpos1 aRobyn L. Tanguay1 aAndrea Terron1 aOmari Bandele00aState of the science on assessing developmental neurotoxicity using new approach methods  uhttps://www.altex.org/index.php/altex/article/view/2882  a121-1440 v423 aThe 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.
Plain language summary Chemicals present in the environment that result in human exposure may alter key biological processes during the development of the human brain. This may contribute to learning disabilities, behavioral disorders, and neurological impairments that are associated with conditions such as autism and attention deficit hyperactivity disorder. Only a few chemicals have been evaluated for such effects in animals, and it is unclear how well animal studies predict human conditions. The workshop brought together stakeholders from international organizations, governmental agencies, industry, and aca­demia to discuss the transition to non-animal tests and other novel approaches to evaluate potential neurodevelopmental effects of chemicals which are more ethical and provide more human-relevant information. The capabilities and limitations of current alternative tests were discussed, and critical next steps to advance the field were outlined.  a1868-8551