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December 2024

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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Sarah Nexus frequently asked questions

Everything you need to know about Sarah Nexus

The use of in silico prediction systems has become an essential part of regulatory submissions when assessing the genotoxic potential of chemicals. Guidelines such as those from the EMA, US FDA, and ICH highlight their importance. Most notably, the ICH M7 guidance explicitly requires the application of two complementary quantitative/qualitative structure-activity relationship ((Q)SAR) systems to

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