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FDA and the Center for Research on Complex Generics (CRCG) workshop

We were thrilled to  attend this workshop to discuss: ‘Mitigation Strategies for Nitrosamine Drug Substance Related Impurities: Quality and Bioequivalence Considerations for Generic Products’.

This event featured vital discussions around risks of forming NDSRIs in certain drug products, strategies to mitigate these risks, and considerations in assessing the safety risks of NDSRI.

Lhasa Limited Principal Scientist, David Ponting, presented ‘Why do nitrosamine potencies vary so widely? Mechanistic rationales for the effects of structural features on activity’.

Find out more about the event.