(Q)SAR models – important tool of risk assessment to support practical implementation of ICH M7 guideline
- 29 сентября 2017
- (Q)SAR, GTIs, ICH M7, генотоксические примеси, квалификация примесей, КССА, мутагенные примеси, принципы валидации, прогнозирование мутагенности, тесты на мутагенность,
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