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Download white paper and journal article on ICH M7 guidelines and implementation

Ahead of their presentation at Extractables & Leachables Europe this November, Leadscope have shared a journal article on 'Prinicples and procedures for implementation of ICH M7 recommended Q(SAR) analyses' and a white paper on 'An expert alert system to predict the mutagenic potential of impurities to support the ICH M7 guideline'.

The journal article, published in February 2016 by Elsevier, outlines a series of principles and procedures to consider when generating (Q)SAR assessments aligned with the ICH M7 guideline to be included in a regulatory submission. 

The white paper, published in May 2016, outlines the development and use of a new expert rule-based system to predict the the results of the bacterial mutagenicity assay.

Glenn Myatt, Chief Scientific Officer at Leadscope presented on 'Regulatory submissions of Q(SAR) results for mutagenicity based on the ICH M7 guideline' at the recent Extractables & Leachables Europe 2016. You can view the full programme here.