(Q)SAR models – important tool of risk assessment to support practical implementation of ICH M7 guideline
- 29 September 2017
- (Q)SAR, genotoxic impurities, GTIs, ICH M7, mutagenic impurities, mutagenicity assay, mutagenicity prediction, qsar validation principles, qualification of impurities,
A general concept of qualification of impurities (or degradation products) is described in the ICH Q3A/B guidelines, whereby qualification is defined as the process of acquiring and evaluating data that establishes the biological safety of an individual impurity (or degradation product) or a given impurity (or degradation) profile at the level(s) specified. Therefore to limit