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SmartTox QSAR Webinar

SmartTox, Lhasa Limited and BioActing discussed QSAR requirements for countries across the globe. Business Development Manager, Raeesah Saddiq gave a demonstration on Lhasa’s in silico toxicology tool Derek Nexus.

Extractables and Leachables USA Conference

Extractables and Leachables USA took place in Arlington, Virginia and online. This conference included presentations from The FDA, Eurofins Medical Device Testing, Thermo Fisher Scientific, Intertek and more. As well as sessions covering industry-leading topics, such as: regulations and standards, extractions and analytical testing, impact assessments, study designs, poster sessions and the future of E&L. Lhasa Senior Scientist, Dr. Martyn Chilton presented a talk at this event, titled ‘Assessing the …

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Webinar | Controlling potentially mutagenic impurities – hear from industry experts!

We were delighted to welcome Andrew Teasdale PhD and Muzaffar Khan PhD to present within our webinar; Controlling potentially mutagenic impurities – hear from industry experts! Andrew is currently the chair of AstraZeneca’s Impurity Advisory Board and has a wealth of knowledge developed over the last 20 years of working within the pharmaceutical industry. He is a leading AZ expert for a number of key impurity …

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How to carry out ICH M7 assessments using in silico tools – A case study for degradation and process impurities

In this webinar, Lhasa Principal Application Scientists, Fernanda Waechter and Diego Zulkiewicz Gomes demonstrated how ICH M7 risk assessments can be performed for impurities in an API, including the following steps: Identification of potential degradation impurities using Zeneth Identification of process related impurities Classification of impurities through Derek Nexus and Sarah Nexus plus expert review Establishing safe limits Evaluating exposure through purge calculations …

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Genotoxic Impurities Summit: Nitrosamines & Beyond

This virtual conference explored opinions on how to tackle the challenges of mutagenic impurities. Specifically, reviewing drug impurity profiling strategies in line with regulatory guidelines, practical insights for compliance with the recent updates in ICH M7 and Q3D, new nitrosamine regulations, determination and calculation of nitrosamine impurities, risk assessment of genotoxic impurities, analytical challenges and …

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