Tools to support the Carcinogenic Potency Categorization Approach (CPCA)

As you may be aware, the US Food and Drug Administration (FDA), the European Medicines Agencies (EMA), and Health Canada have recently released a major update on N-nitrosamine impurities in human medicinal products supporting the categorical prediction of N-nitrosamine potency. The new approach is referred to as the Carcinogenic Potency Categorization Approach (CPCA) and is …

European Medicines Agency Provides Significant Update on N-nitrosamine Impurities

On Friday 7th July 2023, the European Medicines Agency (EMA) released a major update on N-nitrosamine impurities in human medicinal products1,2 including a new approach on determining limits for N-nitrosamines. According to EMA, this approach is expected to contribute the management of products with nitrosamines while ensuring availability of the pharmaceutical drug supply. The Q&A …

Update from QSAR 2023

We recently attended the 20th International Workshop on (Q)SAR in Environmental and Health Sciences (QSAR 2023) held in Copenhagen. It was a great meeting with many interesting topics, including read-across approaches, new methods, and applications of (Q)SARs. We were happy to provide a course on regulatory uses of in silico modelling, covering different applications across …

Assessing carcinogenicity risk of nitrosamines and supporting the ICH S1B guideline

At this year’s SOT in Nashville (March 19-23, 2023), Instem will be organizing two workshops related to cancer assessments.1 In the first workshop, to be held on Tuesday, March 21, 4:30 PM – 5:30 PM (CT) in Room 101B, we will discuss carcinogenicity assessments aligned with the ICH S1B guideline2, specifically focusing on the weight …

Nine Instem Posters at the 2023 SOT Meeting

Instem will again have a large presence at this year’s Society of Toxicology meeting in Nashville.1 As part of the scientific program, we will be co-authoring on nine posters covering the spectrum of scientific topics where we are undertaking research and development activities. This work supports many regulatory mandates and guidelines, including SEND, carcinogenicity risk …

Computational toxicology 2022 year-end review

The computational toxicology group here at Instem has had another busy year that has resulted in six publications and book chapters1-6, completion of existing and initiation of new collaborative working groups, as well as significant updates to our computational toxicology solutions. We have been collaborating on a number of research topics related to the in …

New paper on the use of the Ames assay to predict carcinogenicity of N-Nitrosamines

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 …

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 …