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Regulatory Submission Under ICH M7 - Application of Expert Review

pdf fileJohnston LA; Shannon-Little AL; Nye WE; Yeo D; Snyder SS;

Presented by Dave Yeo at the 2017 SOT Annual Meeting.

The ICH M7 guideline for the assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals permits the use of in silico predictions in place of in vitro testing. The need for two complimenting systems, one expert rule-based and one statistical-based can be fulfilled with Derek Nexus and Sarah Nexus respectively. The guidelines also state that if warranted, the outcome of the in silico predictions can be reviewed by expert knowledge to support the final conclusion. This poster aims to explore the expert review process of in silico results for potentially mutagenic impurities to demonstrate how an expert assessment can provide the basis of a regulatory submission.  It is anticipated that this will facilitate discussion between experts in this field.

All expert calls made on the examples are solely the opinion of experts at Lhasa Limited and are made here for guidance purposes only.


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