For purposes of ICH M7, only mutagenicity is considered - not the broader genotoxicity.
Remember, however, that two QSAR methods (one expert - such as Derek - and one statixstical are required to qualify an impurity for this endpoint/M7 complance.
Shayne
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Shayne Cox Gad ScD PhD
Principal
Gad Consulting Services
Cary NC
United States
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Original Message:
Sent: 03-22-2015 05:19
From: Ramakrishna Padharthi
Subject: DEREK analysis
Hi,
When the report of DEREK says that we have alert for Chromosome damage, should we consider the compound as Genotoxic.
or should we consider it to be genotoxic only if we have alerts for mutagenicity.
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Ramakrishna Padharthi
Ambernath
India
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