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In the ever-evolving landscape of pharmaceutical regulations, staying abreast of the latest guidelines is crucial for ensuring the safety and efficacy of drug products. Recently, the European Medicines Agency (EMA) updated its guidelines to include specific nitrosourea acceptable intake (AI) limits – a class of N-nitroso compounds known for their potential carcinogenicity. In our recent […]
We’re delighted to announce that Molecular Networks and Altamira (MN-AM) have joined our organisation! This marks an important step forward in our mission to advance chemical safety science and reduce the need for animal testing. Building on strong foundations This acquisition builds upon an established partnership – we’ve collaborated closely with both teams for years,
Growing Lhasa: Welcoming Molecular Networks and Altamira Read More »
The recently published paper “Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific acceptable intakes,” presents evidence for evolving the pharmaceutical industry’s approach to N-nitrosamine risk assessment. While the Carcinogenic Potency Categorisation Approach (CPCA) has provided a solid framework for managing N-nitrosamine drug substance-related
Where can N-Nitrosamine data support an alternative AI beyond the CPCA? Read More »
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