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Publications (9)
- Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific acceptable intakes Save
- Regulatory Highlights Save
- Regulatory Highlights Save
- Leveraging ICH M7 Control Options 3 and 4: Discussion and Clarification Using Industrial Case Studies Save
- Regulatory Highlights Save
- Revisiting the Landscape of Potential Small and Drug Substance Related Nitrosamines in Pharmaceuticals Save
- Reflections on the Impact of Nitrosamine Drug Substance Related Impurities Save
- Regulatory Highlights Save
- The Nitrosamine “Saga”: Lessons Learned from Five Years of Scrutiny Save