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    Recommendation on test readiness criteria for new approach methods in toxicology: Exemplified for developmental neurotoxicity.

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    Authors
    Bal-Price, Anna
    Hogberg, Helena T
    Crofton, Kevin M
    Daneshian, Mardas
    FitzGerald, Rex E
    Fritsche, Ellen
    Heinonen, Tuula
    Hougaard Bennekou, Susanne
    Klima, Stefanie
    Piersma, Aldert H
    Sachana, Magdalini
    Shafer, Timothy J
    Terron, Andrea
    Monnet-Tschudi, Florianne
    Viviani, Barbara
    Waldmann, Tanja
    Westerink, Remco H S
    Wilks, Martin F
    Witters, Hilda
    Zurich, Marie-Gabrielle
    Leist, Marcel
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    Type
    Article
    Language
    en
    
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    Title
    Recommendation on test readiness criteria for new approach methods in toxicology: Exemplified for developmental neurotoxicity.
    Published in
    Altex 2018; advance online publication (ahead of print)
    Publiekssamenvatting
    Multiple non-animal-based test methods have never been formally validated. In order to use such new approach methods (NAMs) in a regulatory context, criteria to define their readiness are necessary. The field of developmental neurotoxicity (DNT) testing is used to exemplify the application of readiness criteria. The costs and number of untested chemicals are overwhelming for in vivo DNT testing. Thus, there is a need for inexpensive, high-throughput NAMs, to obtain initial information on potential hazards, and to allow prioritization for further testing. A background on the regulatory and scientific status of DNT testing is provided showing different types of test readiness levels, depending on the intended use of data from NAMs. Readiness criteria, compiled during a stakeholder workshop, uniting scientists from academia, industry and regulatory authorities are presented. An important step beyond the listing of criteria, was the suggestion for a preliminary scoring scheme. On this basis a (semi)-quantitative analysis process was assembled on test readiness of 17 NAMs with respect to various uses (e.g. prioritization/screening, risk assessment). The scoring results suggest that several assays are currently at high readiness levels. Therefore, suggestions are made on how DNT NAMs may be assembled into an integrated approach to testing and assessment (IATA). In parallel, the testing state in these assays was compiled for more than 1000 compounds. Finally, a vision is presented on how further NAM development may be guided by knowledge of signaling pathways necessary for brain development, DNT pathophysiology, and relevant adverse outcome pathways (AOP).
    DOI
    10.14573/altex.1712182
    PMID
    29485663
    URI
    http://hdl.handle.net/10029/621475
    ae974a485f413a2113503eed53cd6c53
    10.14573/altex.1712182
    Scopus Count
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