Innovate

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

In this blog, we explore the value of chemical structure search functionality in Vitic. Structure searching directs our members toward toxicity insights that can help guide their risk and safety assessments. We’ll discuss how chemical structure searches are conducted and the value that a toxicity database like Vitic can bring to decision making. A key

In a recent Lhasa Limited webinar, experts from BfR (the German Federal Institute for Risk Assessment), Syngenta, and Lhasa came together to explore how in silico tools are being used to support genotoxicity assessments. The session delivered a thorough overview of how these advanced computational methods are applied in both regulatory and industry settings, focusing

The ICH M7(R2) Guideline (2023) continues to recommend the bacterial reverse mutation assay (Ames test), conducted in accordance with OECD 471, as a primary tool for assessing the mutagenic potential of pharmaceutical impurities, including nitrosamines. While the Ames test is generally predictive of rodent carcinogenicity, concerns remain about its sensitivity under standard conditions, particularly when