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Webinar - Mirabilis: Controlling potential genotoxic impurities encountered during API synthesis

Burns MJ;

Dr Mike Burns, Scientist at Lhasa, presents on the workings of Mirabilis in relation to assessing risk in accordance with regulatory guidelines.

Controlling potentially mutagenic impurities (PMIs) is a critical part of the development of any pharmaceutical product. The ICH M7 guideline outlines a series of control options that are aligned with risk-based principles. The Mirabilis software has been developed as an industry-standardised in silico tool for the calculation of purge factors of impurities according to the Teasdale approach, led by a cross-industry consortium.

Herein, we present on the development of Mirabilis and describe a theoretical case study which will highlight the process involved when performing a risk assessment aligned to control option 4 for regulatory submission using Mirabilis.

 

 

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