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Managing impurities in Active Pharmaceutical Ingredients (APIs) while meeting ICH M7 can be challenging. The need to quickly identify potential impurities, assess their toxicological risk and ensure compliance with mutagenicity and carcinogenicity guidelines demands a streamlined, reliable process. Held in Spanish, this webinar showcased how in silico tools Zeneth, Derek Nexus, and Sarah Nexus can […]

10 am (EST) / 3 pm (GMT) / 4pm (CET) This webinar detailed how to develop control strategies in line with ICH M7 guidelines without expensive and time-consuming analytical testing. We showed how you can assess carryover risk for potentially mutagenic impurities (including nitrosamines) in your drug development workflow. We were delighted to have Senior

We were delighted to take part in an online seminar and panel discussion with ThermoFisher Scientific on 29th October. Nitrosamine Drug Substance related impurities (NDSRIs) remain a topic of significant concern to the pharmaceutical industry with multiple batch recalls in 2022+ across different drug classes including beta blockers and ACE inhibitors to name but a

Watch our Lhasa webinar to deepen your understanding of the ICH M7 guidelines and their application in classifying mutagenic impurities.   Learn from regulatory and industry leaders through expert presentations and real-world case studies. The webinar agenda includes: Introduction to ICH M7 guidelines Dr Roland Froetschl, from the Federal Institute for Drugs and Medical Devices,

We co-hosted this exciting webinar with BITEK CHEMS on July 17th! The bilingual event was hosted in Korean and included presentations in English from expert Lhasa scientists. BITEK CHEMS are a trusted distributor of Lhasa Limited solutions in South Korea. We were thrilled to be co-hosting this event with BITEK, 14:00 – 15:00 (KST). Featured

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

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