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 »
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
Navigating nitrosamine impurities: An in silico approach to risk assessment Read More »
We had a fantastic time at the 45th Annual Meeting of the American College of Toxicology (ACT 2024), held from 12 – 17th November in Austin, Texas. ACT’s annual meetings embody their mission to “Educate, Lead, and Serve” scientists by providing a forum for exchanging information and perspectives on safety assessment and applied toxicological sciences.
Talking toxicology in Austin: ACT 2024 Read More »
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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