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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).

Join us for an informative webinar where we unveil Acrostic, our novel read-across solution designed to facilitate decision-making when determining AI limits for nitrosamine compounds. Learn how Acrostic utilises a standardised, reliable and transparent framework through worked NDSRI examples.

Our esteemed presenters include:

  • Dr David Ponting, Principal Scientist at Lhasa Limited

David will delve into the background of the Carcinogenic Potency Categorisation Approach (CPCA) for N-nitrosamine impurity assignment and demonstrate how Acrostic complements the CPCA in calculating appropriate AI limits.

  • Dr Charlie Modlin, Senior Application Scientist at Lhasa Limited

Charlie will introduce Acrostic, our innovative in silico read-across tool, and showcase its purposeful workflow through examples, offering insights into how Acrostic evaluates nitrosamine carcinogenicity.

The webinar will conclude with a live Q&A session, providing an opportunity to engage directly with our experts and gain a deeper understanding of using read-across for nitrosamine risk assessment.

Register below to join our read-across masterclass and elevate your understanding of AI limit setting for nitrosamines!

 





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