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Using Data to make Predictions in the Risk Assessment of Mutagenic Impurities

pdf fileStalford SA;

Presented by Susanne Stalford at the 2016 ACS National Meeting and Exposition.

This presentation covers the regulations regarding impurities under ICH M7 as well as the process reasoning behind Mirabilis. The goals and benefits of the Mirabilis projects are highlighted and then an overview of the journey towards an in silico system is given. The current focus of the project is on reactivity-based purge arguments and these arguments are discussed in this presentation. 



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