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Mirabilis: Scientifically Robust Purge Factor Calculations for PMIs in a Synthetic Route

Ott MA;

Presented by Dr. Martin Ott as part of the 2017 vICGM series.

Mirabilis is a knowledge-based software that can estimate the purge of potentially mutagenic impurities (PMI) in drug synthesis. The assessment and control of mutagenic impurities is a key requirement during the development of new drug candidates intended for clinical use.

Mirabilis allows users to enter a full synthetic scheme and identify the PMIs of concern. Based on empirical data, Mirabilis generates a reactivity purge factor for each PMI. These purge factors are included in a report that is suitable for inclusion in a regulatory submission.

This webinar gave an overview of Mirabilis and why it is particularly useful for ICH M7 submissions.


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