Chat with us, powered by LiveChat
Lhasa Logo

August 2023

How well do you know your synthetic process?

Innovate /

Unreported changes to synthetic processes lead to the surprise presence of nitrosamine impurities in marketed drug products. This discovery resulted in the recall of several hypertension, heartburn, and diabetes medications. The nitrosamines crisis While many impurities are introduced directly as reagents, potentially mutagenic impurities (PMIs) arising during manufacture can be harder to identify as they […]

How well do you know your synthetic process? Read More »

Award winning paper paves path to more confident human safety assessments

Discuss /

We are delighted to announce that our paper ‘Using adverse outcome pathways to contextualise (Q)SAR predictions for reproductive toxicity – A case study with aromatase inhibition’ has been selected as the best paper published in Reproductive Toxicology in 2022. The award winning-paper, authored by Lhasa Principal Scientist, Alun Myden, Senior Scientist, Emma White and Head

Award winning paper paves path to more confident human safety assessments Read More »

Current status of the Ames test for N-nitrosamines

Discuss /

In our earlier instalments of the Lhasa blog, we have discussed the latest regulatory insights presented by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Health Canada regarding acceptable intake limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs). Now, our focus zeroes in on the Enhanced Ames Test (EAT) and its

Current status of the Ames test for N-nitrosamines Read More »

What you need to know about the FDA’s new guidance on NDSRIs

Discuss /

The U.S. Food and Drug Administration (FDA) recently took a significant step forward in safeguarding public health by issuing a new guidance titled “Recommended Acceptable Intake Limits for Nitrosamine Drug Substance Related Impurities (NDSRIs) Guidance for Industry.” This important update addresses concerns related to NDSRIs, a group of nitrosamine impurities found in numerous drug products,

What you need to know about the FDA’s new guidance on NDSRIs Read More »

Celebrating Pride at Lhasa: a conversation with Graham Heaven and Margarita Maria Munoz Henao

Life at Lhasa /

At Lhasa, we are empowered by diversity and inclusion, where all voices are heard and celebrated. In our latest blog we caught up with Lhasa Senior Application Scientist, Graham Heaven and Principal Application Scientist, Margarita Maria Munoz Henao, to discuss the significance of Pride and the meaningful ways we can actively support our LGBTQ+ colleagues,

Celebrating Pride at Lhasa: a conversation with Graham Heaven and Margarita Maria Munoz Henao Read More »