Module 3 2019

Drug substance: Other “hot topics”

Impurities

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• Especially for genotoxic impurities where proposed limit / levels exceed threshold but are not qualified. • For genotoxic impurities, derogation for genotoxic drug substances in advanced cancer indications (ICH M7) • Polymorphism / Particle size distribution • For poorly soluble drug substances, the relative solubility of different polymorphs or changes in particle size distribution can lead to clinically-relevant differences in dissolution.

The Organisation for Professionals in Regulatory Affairs