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 AI limits for nitrosamine compounds. Attendees learnt about how Acrostic utilises a standardised, reliable and transparent framework through worked NDSRI examples.
Our esteemed presenters included:
- Dr David Ponting, Principal Scientist at Lhasa Limited
David discussed the Carcinogenic Potency Categorisation Approach (CPCA) for N-nitrosamine impurity assignment and demonstrated how Acrostic complements the CPCA in calculating appropriate AI limits.
- Dr Charlie Modlin, Senior Application Scientist at Lhasa Limited
Charlie introduced Acrostic, our innovative in silico read-across tool, and showcased its purposeful workflow through examples, offering insights into how Acrostic evaluates nitrosamine carcinogenicity.
The webinar concluded with a live Q&A session.