N-nitrosamine risk assessment in pharmaceuticals: Where are we from a regulatory point of view in 2025?

N-nitrosamines have been a concern for decades due to their potential mutagenicity and widespread occurrence across various matrices. While evidence suggests carcinogenicity in animals, their potential carcinogenicity in humans has prompted their initial inclusion in the “cohort of concern” since in...

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Bibliographic Details
Main Authors: Yue Zhang, Joëlle Widart, Eric Ziemons, Philippe Hubert, Cédric Hubert
Format: Article
Language:English
Published: Elsevier 2025-12-01
Series:Journal of Pharmaceutical and Biomedical Analysis Open
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Online Access:http://www.sciencedirect.com/science/article/pii/S2949771X25000350
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