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Anvisa RDC 964/2025: What you need to know about the latest regulatory update

The Brazilian Health Regulatory Agency (Anvisa) has introduced RDC 964/2025, a new guidance that outlines in more detail the requirements for conducting forced degradation studies. This new regulation replaces RDC 53/2015, aligning the requirements for forced degradation studies with international (ICH) standards. By reacting to these regulatory changes, Lhasa has evolved our solution for predicting […]

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Richard Williams memorial award winner

Interview with Caitlin Maggs, winner of the 2024 Richard Williams Memorial Award

The 2024 Richard Williams Memorial Award was proudly presented during the 37th annual Industrial Genotoxicology Group (IGG) meeting in Cambridge last December. This prestigious award, created to honour Dr Richard Williams, celebrates exceptional scientific contributions while supporting early-career researchers in the field of genotoxicology. Last year’s winner, Caitlin Maggs, is a second-year PhD student at

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Where can N-Nitrosamine data support an alternative AI beyond the CPCA?

Where can N-Nitrosamine data support an alternative AI beyond the CPCA?

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

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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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A new life in Leeds at Lhasa 8

Lhasa speaks with the 2023 Richard Williams Award Winner

The Richard Williams Memorial Award, established in 2020, honours the scientific contributions and memory of Dr. Richard Williams. This award recognises exceptional early-career investigators making significant strides in their fields, with winners presenting their work at the Lhasa head office and the Annual Industrial Genotoxicology Group (IGG) Meeting . We are thrilled to introduce the

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10 FAQs About Mirabilis: Pharmaceutical Impurity Control Using In Silico Tools

Identification and control of impurities in active pharmaceutical ingredients (APIs) and pharmaceutical drug products is critical in drug development. Mirabilis is our innovative solution designed to address this challenge. In this post, we’ll answer ten frequently asked questions about Mirabilis.   What is Mirabilis? Mirabilis is an in silico tool developed by Lhasa Limited that

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EUROTOX 2024: A memorable gathering in Copenhagen

EUROTOX 2024: Advancing toxicology in Copenhagen

We had a fantastic time at EUROTOX 2024, held from 8 – 11th September in the picturesque city of Copenhagen, Denmark. This year’s theme, “Toxicology – A Quest for Safe Chemicals and Medicines”, was reflected in the diverse sessions, posters and presentations throughout the event. Key topics ranged from the safety of drugs and environmental

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Did you miss our webinar on degradation chemistry and nitrosamine risk assessment? Here are 5 top takeaways!

If you couldn’t join us for our recent webinar, “Identifying the Formation of Nitrosamines via Degradation Pathways Using an In-Silico Approach,” we’ve got you covered! We explored how Zeneth, our cutting-edge software solution, can help you detect potential degradation issues early in the drug development workflow, specifically in the context of nitrosamine risk assessment. We

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