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Advantages in Utilizing an Integrated In Silico Solution for ICH M7 Expert Review

pdf fileMacmillan D;

Presented by Dr Donna Macmillan at the 2016 American College of Toxicology Annual Meeting.

The ICH M7 guideline permits the expert assessment of mutagenicity based upon two in silico predictions, but does not describe how this should be done. This presentation focuses on the process of expert assessment together with the semi-automated preparation of a report for regulatory submission.


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