Lhasa Limited provides an intuitive and integrated workflow for meeting the ICH M7 guideline, which can be applied to assess and control potentially genotoxic impurities in pharmaceuticals to limit potential carcinogenic risk.
Expert review is a fundamental part of the ICH M7 guideline, permitting expert assessment to support or overturn (Q)SAR predictions. Nexus provides Derek and Sarah Nexus users with the most compound-relevant ICH M7 expert review arguments, which can be used to support an overall call for a compound.
To enhance expert review assessment support, Nexus 2.4 includes a new flag to alert the reviewer when a compound is in the “cohort of concern”. This allows users to limit the use of mutagens that display extremely high carcinogenic potency (cohort of concern) to lower levels of acceptable intake as defined in the ICH M7 guidance.
ICH M7 cohort of concern
The cohort of concern, as outlined in Section 7 of the ICH M7 guideline, comprises 3 classes of high potency genotoxic carcinogens where a compound-specific risk assessment is required. The three classes in the cohort of concern are N-Nitroso, Aflatoxin-like and Alkyl-azoxy compounds. If the query compound is in the cohort of concern, new automatically generated expert review arguments relating to the cohort of concern are presented alongside any other compound relevant arguments.
For a more descriptive overview of the classes flagged for the cohort of concern and the new arguments presented, the full Nexus 2.4 release notes are available for members to access from the Lhasa library now.
Read more about how Nexus supports ICH M7 expert review, in this infographic.
Interested in discovering how Lhasa can assist your ICH M7 expert review? Get in touch with us to find out more!