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ICH M7 Expert Review

ICH M7

Expert assessment is a fundamental part of the evaluation of the mutagenic potential of impurities under the ICH M7 guideline1, which makes a specific provision for the application of expert knowledge to support or overturn a (Q)SAR prediction.

Related documents

pdfICHM7 Classification Workflow (0.54 MB)

pdfNexus Expert Review Support Functionality (an infographic) (0.46 MB)

Overview

Expert assessment is crucial for the evaluation of the mutagenic potential of impurities under the ICH M7 guideline1.

Lhasa Limited provides ICH M7 solutions aimed to offer guidance and support as part of a wider expert review. Chris Barber et al.2 have outlined their views on establishing best practice in the application of expert review under ICH M7.

But what constitutes a positive or negative prediction for bacterial mutagenicity within Lhasa Limited products and how should conflicting results be interpreted?

 

 

Positive Prediction

Negative Prediction
 

Any prediction with a likelihood for mutagenicity of equivocal or higher 

Inactive 

Positive

 Negative

 

Derek and Sarah can be run from within the same Nexus interface to simplify your workflow; however, it is important to remember that they are separate systems, providing completely independent predictions and reports. As such, there are times when these results will contradict each other.

In the case that results are contradicting, an expert review of all available data should be carried out to come to a logical conclusion. Expert review is very important and as such, Lhasa has worked hard to ensure that both Derek and Sarah Nexus provide the right level of information to support an expert analysis, allowing you to come to an informed decision.

The Lhasa ICH M7 decision matrix2 provides an overview of the likely outcome based on your two predictions. However, expert review and additional information can lead to a different expert call.

 

Expert Review Support Functionality

Nexus also provides users with the most compound-relevant ICH M7 expert review arguments, which can be used to support an overall call for a compound. View the full work flow in this Nexus ICH M7 Expert Review Support Functionality Infographic.

 

 

References

  1. ICH M7 Guideline
  2. Barber C., Amberg A., Custer L., Dobo K. L., Glowienke S., van Gompel J., et al. (2015). ‘Establishing best practice in the application of expert review of mutagenicity under ICH M7'. Regul. Toxicol. and Pharmacol.73 367-377
    https://doi.org/10.1016/j.yrtph.2015.07.018

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