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Mutagenic impurities: predicting alerting structures using in silico tools

pdf fileWilliams RV;

Presented by Richard Williams at the 2016 JPAG Symposium.


Recent ICH guidelines have established the use of in silico mutagenicity predictions for the assessment of pharmaceutical impurities to limit potential carcinogenic risk. This regulatory acceptance of in silico toxicity predictions is a significant milestone in the use of (Q)SAR for human risk assessments. This presentation will provide an overview of (i) the theoretical and empirical evidence that supports industrial and regulatory acceptance, (ii) the considerations for (Q)SAR usage within regulatory submissions, (iii) the potential outcomes of in silico mutagenicity predictions and how to deal with uncertainty.


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