Author name: emma.scrafton

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 […]

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 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

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