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 …

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. …

New SD file submission recommendation from the US Food and Drug Administration

Last month, we reviewed some of our Research Collaboration Agreement (RCA) activities with the US Food and Drug Administration (FDA).1 This included a joint project to develop an internal FDA/CDER system (based on the Leadscope technology) to enter, validate, and register chemicals linked to internal (Q)SAR consultation reports. This information, along with access to toxicity …

US FDA collaborations – predicting mutagenicity and beyond…

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. Over the last 15 years I have been working closely with the US Food and Drug Administration (FDA) as a principal investigator on …

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. …

New book on Mutagenic Impurities

We have been really happy to contribute to a number of chapters in an important new book edited by Dr. Andrew Teasdale: “Mutagenic Impurities: Strategies for Identification and Control”1 This will be an essential read for students and professionals in the field of genotoxic impurities (GTIs) assessment covering topics including a history of the regulatory …

N-nitrosamine SAR Working group

Leadscope, Inc. (an Instem company), in collaboration with Lhasa Limited are leading a working group of pharmaceutical toxicologists and consultants investigating the carcinogenic potency and structure-activity relationships of N-nitrosamines. This is in response to the recent discovery of N-nitrosamines in marketed pharmaceuticals and the regulatory changes that have resulted. The working group is run by …

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 …