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

Bal-Price, Anna and Hogberg, Helena T. and Crofton, Kevin M. and Daneshian, Mardas and FitzGerald, Rex E. and Fritsche, Ellen and Heinonen, Tuula and Hougaard Bennekou, Susanne and Klima, Stefanie and Piersma, Aldert H. and Sachana, Magdalini and Shafer, Timothy J. and Terron, Andrea and Monnet-Tschudi, Florianne and Viviani, Barbara and Waldmann, Tanja and Westerink, Remco H. S. and Wilks, Martin F. and Witters, Hilda and Zurich, Marie-Gabrielle and Leist, Marcel. (2018) Recommendation on test readiness criteria for new approach methods in toxicology: Exemplified for developmental neurotoxicity. ALTEX, 35 (3). pp. 306-352.

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Official URL: https://edoc.unibas.ch/77933/

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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).
Faculties and Departments:05 Faculty of Science > Departement Pharmazeutische Wissenschaften > Pharmazie > Regulatory Toxicology (Wilks)
UniBasel Contributors:FitzGerald, Reginald Edward and Wilks, Martin F.
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:Springer Spektrum
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:23 Sep 2020 03:10
Deposited On:21 Aug 2020 13:06

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