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Strengthening the Case for in silico GTI Assessments.pdf

pdf fileBarber CG; Coquin L; Hanser T; Judson PN; Stalford SA; Vessey J; Williams RV;

In silico systems, such as structural alerts, are increasingly being used for the assessment of mutagenicity. Regulatory acceptance of such systems has recently been strengthened by a draft of the ICH M7 guidelines, which supports the use two complementary (Q)SAR prediction systems for assessment of genotoxic impurities (GTIs), one of which should be expert rule-based, and a second, statistically-based system. The basis of this acceptance is that predictive systems can rule out the possibility of mutagenic potential in GTIs. In this work, we have devised and tested a number of methods to enhance Derek Nexus alerts.

Presented by Susanne Stalford at SOT, San Antonio, USA; 10th - 14th March 2013.


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