Publications
- Publisher:Baertschi Consulting LLC
- Publication Date:MAY 2018
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- Publication Type:Presentation
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ICH M7 Overview: Predicting, Assessing, and Controlling Mutagenic Impurities from Degradation
Baertschi SW;Presented by Dr Steven W. Baertschi, Baerstchi Consulting LLC., at the 2018 Pharmaceutical Industry and Regulators Symposium held in Brazil.
This presentation covers the following topics:
- Short overview of ICH M7
- Developing strategies/approaches to predict and assess potential mutagenic degradation products
- Predicting “actual” degradation products in a short timeframe
- Structure alerts and Degradation pathways
- How likely will there be a “problem”?
- Expected Frequency
- Conclusions
