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

Lhasa Limited Principal Scientist, Alun Myden, presented in 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 outputs provide […]

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

Our webinar ‘How to establish acceptable intake limits for NDSRIs’ was hosted in Japanese and contains pre-recorded videos with Japanese subtitles. This virtual event lasted approximately 2 hours. Nitrosamine Drug Substance-Related Impurities (NDSRIs) have emerged as a significant cause for concern within the pharmaceutical industry due to their potential to pose serious health risks to

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Read-across masterclass: How to facilitate your acceptable intake limit setting for nitrosamines

Read-across is a popular data gap filling technique which has recently gained recognition in regulatory guidance as a valuable tool for identifying suitable surrogates in establishing Acceptable Intake (AI) limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs). We held an informative webinar where we unveiled Acrostic, our novel read-across solution designed to facilitate decision-making when determining

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Identifying the formation of nitrosamines via degradation pathways using an in-silico approach

Ensuring the safety of active pharmaceutical ingredients (APIs) is of great importance. A critical aspect of this process involves the identification and mitigation of potentially mutagenic impurities, like nitrosamines. Our in silico tool Zeneth has been used within exploratory formulation departments to understand and account for potential degradation problems within the API at an early stage, resulting

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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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