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

pdf fileBaertschi 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
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