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Manual and Computational Methods for the Evaluation of Statistical Predictions Based on Expert Analysis

pdf fileNye WE; Nudelman R;

Presented by Will Nye, Account Manager, at the 47th ICGM.

Also presented by Will Nye and Raphael Nudelman, Teva Pharmaceutical Industries Ltd., at the GTI conference.


The ICH M7 guideline recommends the use of two complementary (Q)SAR methodologies, one expert rule-based and one statistical-based, to assess the mutagenicity of impurities. The M7 guideline also urges the use of expert review in order to evaluate the relevance of any computational predictions, and such a manual expert evaluation can potentially overrule positive predictions. Although expert review is carried out in all circumstances it can be more challenging when the expert and the statistical system disagree. This disagreement can potentially result in over-control of non-mutagenic impurities.

Teva and Lhasa Limited are developing a more standardised approach for manual expert review using Derek and Sarah Nexus. This approach can improve the speed and accuracy of expert review and also increase the consistency of the overall outcome. This combined presentation will describe the approach, illustrated with worked examples.




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