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Insights into the 2024 Science of Stability Conference

Following the success of the 2022 Science of Stability (SOS) Conference in Philadelphia, we’re excited to announce its return to Barcelona! The 8th SOS will take place on the 13-14th May 2024, and we’re delighted to co-host it with FreeThink Technologies. With a focus on innovation and collaboration, this promises to be a milestone event …

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Have you read this? Benchmarking In silico prediction of pharmaceutical degradation pathways

We are delighted to share our important new open access article: In silico prediction of pharmaceutical degradation pathways: A benchmarking study using the software program Zeneth. The paper, recently published in Organic Process Research & Development (OPRD) is authored by Lhasa Principal Scientist Rachel Hemingway, alongside industry expert co-authors from AstraZeneca, GSK, Pfizer, BMS, Amgen …

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Mitigating the risks of NDSRI’s through data sharing

At Lhasa, we believe in the transformative power of knowledge sharing as the driving force to support the global challenge of nitrosamine risk assessment. Through data sharing and industry collaboration, we empower members to further understand the risks associated with their potential nitrosamine impurities. The Vitic Complex Nitrosamines initiative, launched in 2021 in response to …

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Q&A deep dive with Martin Walter: How to establish AI limits for NDSRIs

Building on the success of our recent webinar, How to establish acceptable intake (AI) limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs), we’re thrilled to present a follow-up that brings you closer to the insightful discussions that unfolded during the interactive Q&A session. In this blog, we’ve gathered questions posed during the webinar and curated written …

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Attendee insights from our Software Crafters Leeds meet-up

We were delighted by the incredible enthusiasm shown by participants at our Software Crafters Leeds event, co-hosted with Codurance. Exploring scientific software development bought together keen coders of all levels for a customised coding-dojo, demonstrating how software can be built to predict complex scientific outcomes. At Lhasa, we understand the significance of knowledge-sharing as a …

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Award winning paper paves path to more confident human safety assessments

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 …

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Current status of the Ames test for N-nitrosamines

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 …

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

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, …

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What does the EMA update on nitrosamine impurities mean for you?

Revised guidance released by the European Medicines Agency (EMA) on 7th July sparked excitement within the scientific community. By unveiling a new system to classify nitrosamines, EMA demonstrates that regulators are supporting industry in solving the complex problem of nitrosamine impurity assessment. The new approach will benefit industry, regulators and ultimately patients. What exactly are the …

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Pharmaceutical Industry and Regulators Symposium: hear from the attendees

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 …

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