An article which superbly illustrates the concepts and principles of Nitrosamines risk assessment applied to the manufacturing of a drug substance.
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Thanks @mflorea !! I want to flag this publication to all our community members.
Secatto et al. l provides a deep dive into a complete and robust risk assessment from the stages of synthesis and equipment evaluation to packaging and stability conditions. Insilico tools are applied and confirmed by analytical testing.
Access: https://pubs.acs.org/doi/10.1021/acs.oprd.3c00487?ref=pdf
In my personal opinion a great reference publication for folks starting their journey on risk assessment. The publication offer a vast amount of information in the supporting section of the publication.
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