The determination of structural similarity to enable read across assessments varies widely between regulators across the globe. In some cases regulators have differed in opinion regarding the most appropriate read across structure with the sponsor company and between multiple regions. Have others encountered this challenge? Is there a way to align across industry regarding computational tools and assignment of appropriate read across structures with a goal of influencing regulatory policy?
1 Like
@lettieredj I could not agree more. @conudel recently shared in a presentation highlighting just that, the need to harmonize acceptance of Q(SAR) and AMES testing.
I’m happy to support and drive any initiative to create such a push, without trying to re-invent the wheel!
This is something we’re very much working on currently; do see the talk from Kevin Cross and myself at the recent QSAR meeting, a version of which has been submitted to the proceedings special issue of Comput. Toxicol. Predicting N-Nitrosamine Activity from SAR , as well as my talk next week at Lhasa’s nitrosamine workshop which will briefly cover some aspects of the SAR and harmonisation 2021 Webinar | Lhasa Limited Nitrosamine Impurity Workshop .
1 Like