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: ICH M7
The Leadscope bacterial mutagenicity expert alerts journey to universal regulatory acceptance
It has taken over 10 years, but now Leadscope’s expert rule-based methodology is used every day to support submissions to regulatory agencies around the world, including pharmaceutical impurity assessments aligned with the ICH M7 guideline1, assessment of extractable and leachables, along with other applications. The following blog reviews this journey. The first step in this …
6-year anniversary of the ICH M7 principles and procedures publication
Over 6 years ago, the ICH M7 pharmaceutical impurities guideline1 was in its implementation phase, and we were approached to consider writing a cross-industry publication to outline a protocol for performing a (Q)SAR assessment aligned with the guideline. A collaborative working group was established and work began to create this publication. The paper was published …
Continue reading “6-year anniversary of the ICH M7 principles and procedures publication”
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 …
Continue reading “Advancing Prediction of Nitrosamine Carcinogenicity Potency”
Streamlining ICH M7 analyses with an implemented protocol
A major focus of our work over the last few years has been on the development and publication of in silico toxicology protocols, discussed in previous blog posts1. This has resulted in a paper outlining a framework for such protocols2 as well as two published protocols in the areas of genetic toxicology3 and skin sensitization4. …
Continue reading “Streamlining ICH M7 analyses with an implemented protocol”
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 …
Continue reading “Establishing potency categories for Nitrosamine impurities”
Can the burden on industry and regulators be reduced?
About 6 years ago, the International Conference on Harmonization (ICH) published the M7 guideline “Assessment and Control of DNA reactive (mutagenic) Impurities in Pharmaceuticals to limit Potential Carcinogenic Risk”.[1] This was a landmark moment for computational toxicology, as it was the first time such methods were recognized by the ICH as a regulatory test. An …
Continue reading “Can the burden on industry and regulators be reduced?”