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Leachables sensitisation assessment framework in collaboration with ELSIE

This enlightening event brought together esteemed members of the Extractables and Leachables Safety Information Exchange (ELSIE) consortium for a captivating discussion on the sensitisation potential of extractables and leachables (E&Ls). Featured presenters and ELSIE consortium members included: Patricia Parris, Global Risk Assessment Services Toxicologist at Pfizer Geraldine Whelan, Regulatory Toxicologist at GSK Martyn Chilton, Principal …

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Performing ICH M7 risk assessment for process impurities and degradation products (in Spanish)

Performing ICH M7 risk assessment for process impurities and degradation products was targeted towards Latin America and carried out in Spanish. In this event, we explored how our software solution, Zeneth, can help you to identify potential degradation impurities in your drug development workflow. We also demonstrated how to classify potentially mutagenic impurities through our …

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Streamlining your drug development workflow using purge calculations (in Japanese)

Join us for our webinar, Streamlining your drug development workflow using purge calculations. This webinar was hosted in Japanese and contained pre-recorded videos with Japanese subtitles. We were delighted to have Senior Principal Scientist Andy Teasdale, presenting in this webinar. Andy is currently the chair of AstraZeneca’s Impurity advisory Board, and has developed a wealth …

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3rd annual genotoxic impurities summit: Nitrosamines & beyond 2023

The safety, quality and clinical results of drug substances and drug products may be disrupted by the formation of nitrosamines along with other mutagenic impurities. The comprehensive development and production of innovative medicines now inevitably involves estimating impurity profiles as well as managing and monitoring them. To meet the demands of ever-increasing regulatory standards and …

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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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How to establish acceptable intake limits for NDSRIs (in Japanese)

Join us for our upcoming webinar, ‘How to establish acceptable intake limits for NDSRIs’. This webinar will be hosted in Japanese and will contain pre-recorded videos with Japanese subtitles. This virtual event will begin at 15.00 (JST) and last approximately 2 hours. Nitrosamine Drug Substance-Related Impurities (NDSRIs) have emerged as a significant cause for concern …

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