ICH M7 Overview: Predicting, Assessing, and Controlling Mutagenic Impurities from Degradation
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