Lhasa Limited shared knowledge shared progress
Publications

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.

Download

Additional Documents

© 2017 Lhasa Limited | Registered office: Granary Wharf House, 2 Canal Wharf, Leeds, LS11 5PS, UK Tel: +44 (0)113 394 6020
VAT number 396 8737 77 | Lhasa Limited is registered as a charity (290866)| Company Registration Number 01765239 (England and Wales).

QuestionPro supports sample survey questions such as multiple choice, drop-down menu, likert-scale, semantic differential, matrix, constant sum, drag-and-drop, slider-scale, net-promoter scale, and many more question types.