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Generics Perspective: Success Strategies for Genotoxic Impurity Identification, Assessment and Control

pdf fileNudelman R;

This presentation looks at the ICH M7 guidelines from a generics perspective and covers 4 key areas:

  • Understanding the basis of the strategy used for GTI identification, assessment and control
  • The key pitfalls and suggestions for overcoming them
  • The use of in silico tools and (Q)SAR as part of the assessment strategy
  • The impact of ICH M7 on GTI assessment strategies.

Presented by Dr. Raphael Nudelman at the Genotoxic Impurities conference, London, UK; 10th June 2015.

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