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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

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

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

We were delighted to host a webinar in Japanese, titled ‘How to predict for the formation of NDSRIs’. 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

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

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

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

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