Module 3 Presentations

14/05/2024

Drug substance: Other “hot topics”

• Impurities • 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) • Nitrosamines are a class of genotoxic impurity for which a risk assessment (drug product) is mandatory; often stem from the drug substance. • 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

23

Major deficiencies in Drug Products

The Organisation for Professionals in Regulatory Affairs

24

12