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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 […]

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,

Join us as we look back at the highly anticipated 4th instalment of the Pharmaceutical Industry and Regulators Symposium, held at the prestigious Auditório do Conselho Federal de Farmácia in Brasilia. Packed to capacity, this event was a resounding success, attracting industry experts and regulatory authorities across Brazil. What is the Pharmaceutical Industry and Regulators

We had a fantastic time at this year’s Society of Toxicology (SOT) in Nashville, Tennessee, where Principal Scientist, Dr. Martyn Chilton was shortlisted for two Best Overall Abstract awards!  Martyn was awarded ‘Top 10 Best Computational Toxicology Specialty Section (CTSS) Abstract’ and ‘Top 10 Best Risk Assessment Speciality Section (RASS) Abstract’ for his poster which

In November last year, we published a ground-breaking article to Chemical Research in Toxicology titled ‘What Makes a Potent Nitrosamine? Statistical Validation of Expert-Derived Structure–Activity Relationships’.   Within the paper, we show that certain structural features, when treated independently, have a statistically significant impact on the carcinogenic potency of nitrosamines. It is with great excitement that

Welcome to 2023, I hope you are feeling enthusiastic about the year ahead. I am not one for New Year’s resolutions, however, I do have a sense of excitement about the opportunities that a New Year brings. For us at Lhasa, 2023 marks the end of our BHAG period. If you are wondering, “What on earth is

Data sharing initiatives allow researchers and scientists to share data and knowledge in order to improve and accelerate scientific progress and discovery. These initiatives are therefore at the heart of our Lhasa Limited ethos “Shared knowledge, shared progress“. In response to the nitrosamine crisis, we partnered with the pharmaceutical industry to launch a data sharing

As we begin this year, I am optimistic that we are now through the worst of the COVID-19 pandemic, that has affected so many of us. I am hopeful that 2022 will allow us to focus less on the pandemic and more on doing great things. One of the things I have missed the most

“Upon becoming a member of Lhasa Limited, a world of opportunity opened up, both for the acquisition of new tools and for opportunities to actively participate in the consortia promoted by Lhasa, where there is a very important exchange of knowledge between professionals in the field.” Mariah Ultramari, Spektra Consultoria At Lhasa, we’re proud to