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

ABSTRACT: 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,

SUBMITTER: Bal-Price A 

PROVIDER: S-EPMC6545888 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature