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Nitrosamine Drug Substance-Related Impurities (NDSRIs) have become a major concern in the pharmaceutical industry due to their potential to pose serious health risks to patients. Understanding how to predict and manage the formation of NDSRIs is vital to ensure the highest quality and safety standards are met in drug development and manufacturing processes. In this […]

We were thrilled to be joined by a distinguished panel of experts to discuss how to establish acceptable intake (AI) limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs). NDSRIs have emerged as a significant cause for concern within the pharmaceutical industry due to their potential to pose serious health risks to patients. In order to facilitate

Lhasa Principal Scientist, Rachel Hemingway, presented; Use of an in silico tool to determine the molecular susceptibility of compounds forming nitrosamine degradation products, as part of FreeThink Technologies Nitrosamine webinar series. In the webinar, Rachel addressed: How can an in silico tool help with nitrosamine assessments?  What chemical space is covered?   Case studies: NDSRIs  How can a

This virtual event explored how our in silico software solution Zeneth can help you identify forced degradation pathways of organic compounds, which can support characterization of structures of degradants. Real life case studies demonstrated how this can be applied to analytical development, formulation and nitrosamine risk assessment. Principal Application Scientist, Margarita Munoz-Henao discussed the benefits

Thank you to those who attended our webinar, ‘Streamlining your drug development workflow using purge calculations’. We were delighted to have Senior Principal Scientist Andy Teasdale presenting . Andy is the chair of AstraZeneca’s Impurity advisory Board, and has developed a wealth of knowledge over the last 30 years working in the pharmaceutical industry. He

We recently held our webinar ‘Harnessing cutting-edge carcinogenicity data to support your toxicity assessments’. In this free to-attend virtual event, Lhasa Senior Scientist, Andrew Thresher presented the latest innovations in the Lhasa Carcinogenicity Database (LCDB). The LCDB is a freely available database of in vivo carcinogenicity study information, which includes TD50 values as a measure

In this Lhasa webinar we discussed alternative approaches to carcinogenicity assessment with Dr. Todd Bourcier (FDA) and Dr. Gina Hilton (PETA). Within many sectors of the life sciences industry, animal testing is still considered a primary option for toxicity testing, and as a result is used heavily. The limitations of this model are now well

We were thrilled to  attend this workshop to discuss: ‘Mitigation Strategies for Nitrosamine Drug Substance Related Impurities: Quality and Bioequivalence Considerations for Generic Products’. This event featured vital discussions around risks of forming NDSRIs in certain drug products, strategies to mitigate these risks, and considerations in assessing the safety risks of NDSRI. Lhasa Limited Principal

We were pleased to attend the FDA/HESI Roadmap Planning on Hazard and Risk Assessment of Nitrosamine Impurities in Drugs workshop. Organised by the FDA and HESI, this exciting event offered attendees the opportunity to engage in important discussions around the assessment of nitrosamines, including Nitrosamine Drug Substance-related Impurities (NDSRI). Lhasa Principal Scientist, David Ponting presented