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Author name: Aimee Ellam

How to overcome the challenges of manual read-across when assessing nitrosamine acceptable intake limits

How to overcome the challenges of manual read-across when assessing nitrosamine acceptable intake limits

Nitrosamines, a class of chemical compounds known for their potential carcinogenic properties, have become a significant concern for the pharmaceutical industry. In line with revised guidance from the European Medicines Agency (EMA), regulatory agencies require N-nitrosamines risk assessments to be performed on all marketed medical products investigating nitrosamine formation potential and their mutagenic and carcinogenic

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