Chat with us, powered by LiveChat Discuss | Lhasa Limited

Discuss

Explore topical blogs discussing chemical safety assessment.

fda ltl nitrosamines cover 1080x864 1

FDA acceptance of less-than-lifetime (LTL) adjustment for nitrosamine impurities: what you need to know

by David Ponting, Senior Principal Scientist, Lhasa Limited On 24 September 2026, the US Food and Drug Administration (FDA) published a guidance update, “Application of Less-Than-Lifetime Adjustment to Nitrosamine Impurities”, on the Center for Drug Evaluation and Research (CDER) nitrosamine guidance web page. For the first time, the FDA accepts that less-than-lifetime (LTL) adjustment factors,

FDA acceptance of less-than-lifetime (LTL) adjustment for nitrosamine impurities: what you need to know Read More »

Forced degradation study design Zeneth ICH Q1A(R2)

How Zeneth Soft Spots Supports confident ICH Q1A(R2) Forced Degradation Study Design

Forced degradation study design that is both defensible and efficient requires insight into the specific reactivity of an API before work begins in the lab. For a structurally complex molecule, each ICH Q1A(R2) stress condition can implicate multiple functional groups and competing degradation pathways, the challenge is not generating predictions, but knowing which degradation sites

How Zeneth Soft Spots Supports confident ICH Q1A(R2) Forced Degradation Study Design Read More »

What’s next for nitrosamine qualification? Key insights from industry experts

What’s next for nitrosamine qualification? Key insights from industry experts

Nitrosamine qualification remains one of the most complex and fast-moving areas in pharmaceutical safety assessment. As scientific understanding advances and regulatory expectations continue to evolve, organisations are increasingly looking beyond one-size-fits-all approaches to support confident, scientifically justified decisions. In our recent webinar, Science-led approaches to nitrosamine qualification and safety assessment, Dr Joel Bercu and Dr

What’s next for nitrosamine qualification? Key insights from industry experts Read More »

Bridging prediction and regulation in pharmaceutical science across latin america at the lhasa symposium 2026

Bridging Prediction and Regulation in Pharmaceutical Science across Latin America

Join us for a recap of the Lhasa Pharmaceutical Science Symposiums held in Colombia and Argentina in March 2026. Participants gained a clearer understanding of how in silico approaches can be applied to assess a variety of impurities, exploring these tools for themselves during demonstration sessions and through real-world case studies shared by Lhasa Limited.

Bridging Prediction and Regulation in Pharmaceutical Science across Latin America Read More »

Read our blogon Metabolite ID and toxicity assessment of metabolites

Confident metabolite ID and metabolite toxicity assessment with Meteor

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 relaunch

Confident metabolite ID and metabolite toxicity assessment with Meteor Read More »

Blog image 9

Problem solving using toxicology risk assessment software

In today’s chemical safety landscape, scientists need reliable data to make confident decisions. Challenges in workflows has resulted in toxicology risk assessment software continuing to evolve alongside the advancements seen across the regulatory landscape and the developing methodologies that meet guidelines. Vitic is Lhasa Limited’s expertly curated toxicity database, developed to support informed decision-making in

Problem solving using toxicology risk assessment software Read More »

Strengthening mutagenicity and genotoxicity assessment with complementary (Q)SAR

Strengthening mutagenicity and genotoxicity assessment with complementary (Q)SAR

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

Strengthening mutagenicity and genotoxicity assessment with complementary (Q)SAR Read More »

Lhasa Limited shortlisted for the Lush Prize 2026 for science, advancing non-animal approaches to DART through human-relevant, in silico toxicology.

We’ve been shortlisted for the Lush Prize 2026 – Science

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

We’ve been shortlisted for the Lush Prize 2026 – Science Read More »

Lhasa publication awards for chemical safety achievement

2025 Lhasa Publication Awards: The leading research in chemical safety

Just before the holiday period, our community voted on the most impactful scientific papers of the year authored by industry and regulatory experts and co-authored with Lhasa Limited. These awards recognise the work driving progress in toxicology and chemistry. They highlight the vital collaborative efforts between our scientists and industry partners, helping to shape the

2025 Lhasa Publication Awards: The leading research in chemical safety Read More »

Lhasa Limited 2025 Wrap-up

Lhasa 2025 wrap-up: New milestones in regulatory science and safety assessment

Curious to find out what we’ve been up to in 2025? This year, we have driven advancements in regulatory science, delivered innovation in chemical safety software, and built stronger global collaborations. Watch our 2025 wrap-up Click the button above to jump to the video, or read all about our milestones below. One of our standout

Lhasa 2025 wrap-up: New milestones in regulatory science and safety assessment Read More »