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Use of an in silico tool to determine the molecular susceptibility of compounds forming nitrosamine degradation products

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 …

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Supporting analytical development, formulation and nitrosamine risk assessment in the pharmaceutical industry

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 …

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Streamlining your drug development workflow using purge calculations

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 …

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Integrating ReproTracker into DART AOP Frameworks for mechanism-based teratogenicity assessment

Lhasa Limited Principal Scientist, Alun Myden, to present in upcoming webinar hosted by Toxys on the use of DART AOP frameworks for mechanism-based teratogenicity assessment.   Testing for developmental toxicity according to the current guidelines requires large numbers of animals. In addition to the ethical considerations and high costs of these traditional animal models, the …

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Harnessing cutting-edge carcinogenicity data to support your toxicity assessments

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 …

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Using next generation carcinogenicity assessments to make confident human safety decisions

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 …

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FDA and the Center for Research on Complex Generics (CRCG) workshop

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 …

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FDA/HESI Roadmap Planning on Hazard and Risk Assessment of Nitrosamine Impurities in Drugs workshop

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 …

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Nonclinical Carcinogenicity Studies: Fundamentals, Case Studies and Regulatory Trends

Dr. Susanne Stalford, Lhasa Principal Scientist, presented within a Pharmaceutical & BioScience Society workshop, on the topic of Nonclinical Carcinogenicity Studies. The workshop included presentations from regulatory and industry perspectives, on topics relating to carcinogenicity assessment of pharmaceuticals, including: The challenges faced with carcinogenicity assessments, in the development of pharmaceuticals Regulatory and industry perspectives on …

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Supporting mutagenic impurity and degradant risk assessment using an in silico approach

We recently held our first webinar of 2023, ‘Supporting mutagenic impurity and degradant risk assessment using an in silico approach’. This free-to-attend webinar featured talks from Dr. Andreas Broehl, Laboratory Head at Bayer Pharmaceuticals, and Lhasa Limited Senior Scientist, Dr. Ash Ali. In this exciting virtual event, we explored how our in silico software solution Zeneth, can …

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