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Author name: Aimee Ellam

Navigating nitrosamine impurities with Lhasa

Navigating nitrosamine impurities: An in silico approach to risk assessment

In the ever-evolving landscape of pharmaceutical development, ensuring the safety and efficacy of medications is paramount. One of the emerging challenges in this field is the detection and management of nitrosamine impurities—potentially carcinogenic compounds that can form during drug manufacturing. To address this, having a robust workflow for nitrosamine impurity risk assessments is essential. In […]

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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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