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Understanding the metabolic fate of compounds is a requirement for safe pharmaceutical development. Whether supporting early-stage drug discovery, conducting impurity qualification for generics, or preparing data for regulatory submissions, scientists require transparent, scientifically credible predictions aligned with global guidance.   As a member-driven and not-for-profit organisation, we have developed Meteor to meet these needs. Our […]

Mutagenicity assessment is no longer debated; it is embedded within regulatory science. The more important question today is not whether in silico models should be used, but how confidently and transparently their outputs are interpreted. Under ICH M7, the mutagenic potential of pharmaceutical impurities must be evaluated using two complementary in silico methodologies, one expert

We’re delighted to share that Lhasa Limited has been shortlisted for the Lush Prize 2026 in the Science category, an award recognising research teams whose work is most likely to lead to practical, regulator-accepted non-animal testing approaches. The Lush Prize exists to accelerate the transition to 21st-century toxicology, with the ultimate goal of ending the

Insights on ICH Q3E, Extractables & Leachable (E&L) and risk assessment submissions Interpreting grey areas in the draft ICH Q3E guideline Earlier this month, the Lhasa Limited team, alongside Dr Lance Molnar, Head of Non-Clinical Operations and Risk Assessments at Viatris, and Dr Patricia Parris, Toxicology Impurity Risk Management at Pfizer, attended the Smithers E&L

Following our recent Lhasa Limited hosted webinar, ICH S1B(R1): industry and regulatory best practice for confident carcinogenicity assessment, attendees had the rare opportunity to engage directly with experts who helped shape the ICH S1B(R1) Addendum. The ICH S1B(R1) Addendum is a globally recognised guideline that introduces a weight-of-evidence (WoE) approach to assessing the carcinogenic potential

In this latest blog, we will define the difference between certainty and uncertainty in the ICH M7 guideline for mutagenic impurities. Delving into the power of existing experimental data, we’ll address how Vitic’s expert toxicity database can accelerate the workflow of Classes 1, 2 and 5 in mutagenicity risk assessments. To Toxicologists, the ICH M7

Carcinogenicity assessment is a critical step in drug development. Teams must balance regulatory compliance, development timelines, and ethical testing, often with incomplete datasets. The revised ICH S1B(R1) guideline introduces a weight-of-evidence (WoE) approach that provides a more structured, efficient, and human-relevant path forward. By applying this framework, organisations can benefit from: $2 – 4M cost