ICH M7 – Best Practise in Assessing the Mutagenic Potential of Impurities Using In Silico Methodologies
Scott McDonald, Lhasa Limited, gave this presentation at the “Streamlining Drug Discovery” symposia held in Shanghai, China on 31 May 2018 and Tokyo, Japan on 5 June 2018.
Expert assessment is a fundamental part of the assessment of the mutagenic potential of impurities under the ICH M7 guideline and it makes a specific provision for the application of expert knowledge to support or overturn an in silico prediction. Whilst expert assessment has been successfully applied in this context, there remains some uncertainty as to what constitutes expert analysis.
This presentation will outline a framework to more clearly understand the process of expert assessment under ICH M7 and the role that both in silico prediction methodologies and supporting data play. The use of such a framework can assist in dealing with relatively straightforward situations where the two required in silico methodologies agree to more complicated cases of model disagreement or “indeterminate” or “out-of-domain” predictions.
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