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