Title: Perspectives on Validation of High-Throughput Pathway-Based Assays Supporting the 21st Century Toxicity Testing Vision
Authors: JUDSON RICHARDKAVLOCK ROBERTMARTIN MATTREIF DAVIDHOUCK KEITHKNUDSEN THOMASRICHARD ANNTICE RAYMONDWHELAN MAURICEXIA MENGHANGHUANG RUILIAUSTIN CHRISTOPHERDASTON GEORGEHARTUNG THOMASFOWLE III JOHN R.WOOGE WILLIAMTONG WEIDADIX DAVID
Citation: ALTEX-ALTERNATIVES TO ANIMAL EXPERIMENTATION vol. 30 no. 1 p. 51-56
Publisher: SPEKTRUM AKAD VERLAG
Publication Year: 2013
JRC N°: JRC69205
ISSN: 1868-596X
URI: http://publications.jrc.ec.europa.eu/repository/handle/JRC69205
Type: Articles in periodicals and books
Abstract: In vitro, high-throughput screening (HTS) assays are seeing increasing use in toxicity testing. HTS assays can simultaneously test many chemicals, but have seen limited use in the regulatory arena, in part because of the need to undergo rigorous, time-consuming formal validation. Here we discuss streamlining the validation process, specifically for prioritization applications in which HTS assays are used to identify a high-concern subset of a collection of chemicals. The high concern chemicals could then be tested sooner rather than later in standard guideline bioassays. The streamlined validation process would continue to ensure the reliability and relevance of assays for this application. We discuss the following practical guidelines: (1) follow current validation practice to the extent possible and practical; (2) make increased use of reference compounds to better demonstrate assay reliability and relevance; (3) deemphasize the need for cross-laboratory testing, and; (4) implement a web-based, transparent and expedited peer review process.
JRC Directorate:Health, Consumers and Reference Materials

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