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|Title:||Genetic toxicology in silico protocol|
|Authors:||HASSELGREN CATRIN; AHLBERG ERNST; AKAHORI YUMI; AMBERG ALEXANDER; ANGER LENNART T; ATIENZAR FRANCK; AUERBACH SCOTT; BEILKE LISA D.; BELLION PHILLIP; BENIGNI ROMUALDO; BERCU JOEL; BOOTH EWAN D; BOWER DAVE; BRIGO ALESSANDRO; CAMMERER ZORYANA; CRONIN MARK; CROOKS IAN; CROSS KEVIN P.; CUSTER LAURA; DOBO KRISTA; DOKTOROVA TATYANA; FAULKNER DAVID; FORD KEVIN A.; FORTIN MARI C; FRERICKS MARKUS; GAD-MCDONALD SAMANTHA E; GELLATLY NICHOLA; GERETS HELGA; GERVAIS VÉRONIQUE; GLOWIENKE SUSANNE; VAN GOMPEL JACKY; HARVEY JAMES; HILLEGASS JEDD; HONMA MASAMITSU; HSIEH JUI-HUA; HSU CHIA-WEN; BARTON-MACLAREN TARA; JOHNSON CANDICE; JOLLY ROBERT; JONES DAVID; KEMPER RAY; KENYON MICHELLE; KRUHLAK NAOMI; KULKARNI SUNIL A; KUEMMERER KLAUS; LEAVITT PENNY; MASTEN SCOTT; MILLER SCOTT; MOUDGAL CHANDRIKA; MUSTER WOLFGANG; PAULINO ALEXANDRE; LO PIPARO ELENA; POWLEY MARK; QUIGLEY DONALD P.; REDDY M VIJAYARAJ; RICHARZ ANDREA; SCHILTER BENOÎT; SNYDER RONALD D.; STAVITSKAYA LIDIYA; STIDL REINHARD; SZABO DAVID T; TEASDALE ANDREW; TICE RAYMOND R.; TREJO-MARTIN ALEJANDRA; VUORINEN ANNA; WALL BRIAN A; WATTS PETE; WHITE ANGELA; WICHARD JOERG; WITT KRISTINE; WOOLLEY ADAM; WOOLLEY DAVID; ZWICKL CRAIG; MYATT GLENN|
|Citation:||REGULATORY TOXICOLOGY AND PHARMACOLOGY vol. 107 no. 104403 p. 1-21|
|Publisher:||ACADEMIC PRESS INC ELSEVIER SCIENCE|
|Type:||Articles in periodicals and books|
|Abstract:||In silico toxicology (IST) approaches to rapidly assess chemical hazard, and usage of such methods is increasing in all applications but especially for regulatory submissions, such as for assessing chemicals under REACH as well as the ICH M7 guideline for drug impurities. There are a number of obstacles to performing an IST assessment, including uncertainty in how such an assessment and associated expert review should be performed or what is fit for purpose, as well as a lack of confidence that the results will be accepted by colleagues, collaborators and regulatory authorities. To address this, a project to develop a series of IST protocols for different hazard endpoints has been initiated and this paper describes the genetic toxicity in silico (GIST) protocol. The protocol outlines a hazard assessment framework including key effects/mechanisms and their relationships to endpoints such as gene mutation and clastogenicity. IST models and data are reviewed that support the assessment of these effects/mechanisms along with defined approaches for combining the information and evaluating the confidence in the assessment. This protocol has been developed through a consortium of toxicologists, computational scientists, and regulatory scientists across several industries to support the implementation and acceptance of in silico approaches.|
|JRC Directorate:||Health, Consumers and Reference Materials|
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