Archive

Many readers will be aware of the risk posed by nitrosamine impurities, as an ongoing pharmaceutical industry hot topic. In July 2021 ANVISA published their guidance for assessment and control of potentially carcinogenic nitrosamines in active pharmaceutical ingredients and drug products. To discuss this topic, we invited knowledgeable speakers from ANVISA, Industry - GSK and Libbs Farmacêutica - and Lhasa to give their perspectives on this topic. This article details the top 20 take away points from the workshop for quick and easy consumption - enjoy!

As a member-based organisation, anticipating and supporting the needs of our members is critical. 

A key requirement of ICH M7 is to use two complementary (Q)SAR methodologies, one expert rule-based and the second statistical-based. This blog article recognises the benefits provided when in silico systems are integrated to provide a full ICH M7 assessment in one environment.

Discover how Lhasa Limited can help make mutagenicity assessment a simpler task, in this article!

In his blog “Human review of in silico predictions of toxicity”, Principal Scientist, Alex Cayley, outlined the reasons why expert review is essential when using in silico tools to assess toxicity, particularly in the ICH M7 use case where expert review of two complementary in silico systems is required [1].

In this post we discuss how consideration of the user’s journey led to Lhasa tackling the ICH M7 use case with a brand-new automated workflow, now available to Derek and Sarah users in Nexus 2.3. I’ll also show some worked examples of results from the new system.

The recent discovery of N-nitrosamine (nitrosamine) impurities in several marketed pharmaceuticals has led to a requirement for further investigation into nitrosamine mutagenic and carcinogenic activity. Regulatory requirements mean that marketing authorisation holders for human medicines, containing chemically synthesised active substances, must review their medicines for the possible presence of nitrosamines and test all products at risk. Risk-based approaches to prioritise evaluations and subsequent confirmatory testing may be used. These assessments must be completed by October 2020, generating a significant challenge for the pharmaceutical industry.

One of the most important ingredients for an effective team is trust, and a critical phase of team building is starting to develop that sense of trust – to be strong has to be earnt and regularly reinforced; it is rarely simply given! The same is true when using in silico models and by mirroring the natural approaches – the intuitive tests that we apply either consciously or subconsciously - we can understand how and when a model can be effectively used.