Glowienke, Susanne and Marterer, Wolfgang (2014) Use of a second, statistically based (Q)SAR (Quantitative Structure Activity Relationships)methodology in Genotoxin Risk Assessment (GRA)assessment of DNA reactive (mutagenic) impurities: Challenges and Opportunities. Use of a second, statistically based (Q)SAR (Quantitative Structure Activity Relationships)methodology in Genotoxin Risk Assessment (GRA)assessment of DNA reactive (mutagenic) impurities: Challenges and Opportunities.

Abstract

The proposed ICH (International Conference on Harmonization) guidance on genotoxic DNA reactive (mutagenic) impurities (ICH M7) has recently received step 2 approval (1). One of the most significant changes in the way Industry approaches Genotoxin Risk Assessment (GRA) of API (active pharmaceutical ingredient) and drug products is the new requirement to utilize two complementary (Q)SAR (Quantitative Structure Activity Relationships) methodologies for structure-based assessment.
The paper will contain case studies on in silico evaluations of drug substance synthesis schemes of differernt companies using 2 QSAR systems. I am asking for permission to share the Novartis case study BEP800. I already have permission from TRD and the external company to use BEP800 for this paper.

Item Type:	Article
Date Deposited:	28 Apr 2016 23:45
Last Modified:	28 Apr 2016 23:45
URI:	https://oak.novartis.com/id/eprint/21362