Dear community a really good reference for all things Mutagenic Impurities. @AndyTeasdale is a recognized leader and reference on this topic.
Book on control of mutagenic impurities is now available to pre-order, with a discount. Some ten years after the first book, this is a significant re-write addressing all aspects of MI risk assessment, incorporating of course a discussion of N-Nitrosamines which was arguably the largest mutagenic impurity issue ever faced by the pharmaceutical industry.
Readers will also benefit from the inclusion of:
• A thorough introduction to the development of regulatory guidelines for mutagenic and genotoxic impurities, including a historical perspective on the development of the EMEA guidelines and the ICH M7 guideline
• An exploration of in silico assessment of mutagenicity, including use of structure activity relationship evaluation as a tool in the evaluation of the genotoxic potential of impurities
• A discussion of a toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential of common synthetic reagents
