This week, we are pleased to welcome Dr. Kevin P. Cross, Instem’s Principal Investigator with U.S. FDA Collaborations and VP of Product Engineering and Production, as a guest contributor to the blog. We were happy to contribute to a recent publication titled “Use of the Bacterial Reverse Mutation Assay to Predict Carcinogenicity of N-Nitrosamines”.1 N-Nitrosamines …
Tag archives: Nitrosamines
Advancing Prediction of Nitrosamine Carcinogenicity Potency
This week, Dr. Kevin Cross from Instem is presenting at the 2022 Genetic Toxicology Association meeting on recent progress in predicting N-nitrosamine carcinogenicity potency. The presentation outlines progress over the last year and provides an update on different collaborative working groups, including a recently announced EMA-MutAmind project funded by the European Medicine’s Agency and led …
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New book on mutagenic impurities
We were delighted to contribute to a new book on Mutagenic Impurities, edited by Andrew Teasdale – “Mutagenic Impurities: Strategies for Identification and Control”.1 The book incorporates a discussion on the ICH M7 guideline and covers the in silico assessment of mutagenicity, including the use of structure-activity relationship methodologies, to support the evaluation of impurities. …
Four papers accepted for publication
Over the last couple of weeks, we have received news that four papers, submitted earlier this year to the Journal of Computational Toxicology, have been accepted for publication. Developing Structure-Activity Relationships for N-Nitrosamine Activity1 This paper outlines N-Nitrosamine carcinogenic potency ranges and describes specific structural features that have clear effects on these ranges. It highlights …
Computational toxicology at the SOT 2021 Meeting
We are happy to be presenting at this year’s virtual SOT meeting1 on a number of topics throughout the course of the event. On Monday 15th March at 3pm (EST), we are covering some new areas at the session “Hot Topics in Computational Toxicology: New Developments that Support Regulatory Submissions.” This includes a discussion on …
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Establishing potency categories for Nitrosamine impurities
Nitrosamine impurities currently belong to a “cohort of concern” because of their potential to be potent mutagenic carcinogens, as described in the ICH M7 guideline1. They are also coming under increasing regulatory scrutiny with the US Food and Drug Administration and European Medicines Agency recently issuing new guidelines2,3 for examination of this class. These guidelines …
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