ICH M7 assessment and classification of drug impurities
Expert Reviews of mutagenicity predictions
Limits setting for drug impurities
Prediction of degradation pathways or API-excipient interactions/incompatibilities
Nitrosamines risk assessment
Qualification of non-genotoxic drug impurities and specification justifications
Purge factor calculations and decisions regarding the Control Option 4 of mutagenic impurities
Other





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