Progress on Building a Tool for Predicting the Purging of Mutagenic Impurities During Synthesis
Still in its project phase, Mirabilis is the result of a continuing collaboration between Lhasa Limited and various pharmaceutical industry partners, to develop a systematic approach for the risk assessment of potentially mutagenic impurities remaining in a final drug product when introduced or created during synthesis.
In this presentation, Andrew Teasdale of AstraZeneca gave an update on the Mirabilis project. His presentation features an introduction to the purge tool concept and how it relates to ICH M7, with illustrative examples and an overview on his experience on the use of purge for regulatory submissions. A recording of his presentation is available by clicking the "Visit site" button and slides are available from the Additional Documents section below.
Following his presentation, William Drewe of Lhasa Limited gave a short demonstration of the latest version of Mirabilis, which can be seen by watching the video in the Additional Documents section below.