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The importance of expert review to clarify ambiguous situations for (Q)SAR predictions under ICH M7. | LitMetric

AI Article Synopsis

  • - The ICH M7 guideline suggests the use of in silico predictions for evaluating bacterial mutagenicity with the help of two complementary Q(SAR) models to improve prediction sensitivity and accuracy.
  • - The 4th ICH M7/QSAR Workshop featured discussions on expert review of ambiguous (Q)SAR results using 20 specific compounds, highlighting the importance of reviewing conflicting predictions.
  • - Dr. Chris Barber showcased reviews using Derek Nexus and Sarah Nexus tools, which identified common issues in the predictions, leading to the proposal of standardized arguments for future assessments.

Article Abstract

The use of in silico predictions for the assessment of bacterial mutagenicity under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) M7 guideline is recommended when two complementary (quantitative) structure-activity relationship (Q)SAR models are used. Using two systems may increase the sensitivity and accuracy of predictions but also increases the need to review predictions, particularly in situations where results disagree. During the 4th ICH M7/QSAR Workshop held during the Joint Meeting of the 6th Asian Congress on Environmental Mutagens (ACEM) and the 48th Annual Meeting of the Japanese Environmental Mutagen Society (JEMS) 2019, speakers demonstrated their approaches to expert review using 20 compounds provided ahead of the workshop that were expected to yield ambiguous (Q)SAR results. Dr. Chris Barber presented a selection of the reviews carried out using Derek Nexus and Sarah Nexus provided by Lhasa Limited. On review of these compounds, common situations were recognised and are discussed in this paper along with standardised arguments that may be used for such scenarios in future.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7510098PMC
http://dx.doi.org/10.1186/s41021-020-00166-yDOI Listing

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