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 …
Continue reading “Tools to support the Carcinogenic Potency Categorization Approach (CPCA)”
Klimisch Score and the Reliability Score
In Silico methods are used to predict a toxicological outcome directly from the chemical structure. In general, the state-of-the-art is to use multiple methodologies in combination with an expert review of prediction results.1 These approaches are used either as a direct replacement for an in vitro or in vivo assay or a part of a …
Continue reading “Assessing whether In Silico models are fit-for-purpose”
Instem will host an ICH S1B and data sharing session at Eurotox 2023.
The US Food and Drug Administration Update on N-nitrosamine Impurities.
In silico toxicology refers to computational methods that predicts toxicological endpoints or mechanisms. It offers a cost-effective, rapid, and animal-free approach to support toxicological hazard assessments. There are increasing numbers of applications where it has been shown that in silico toxicology can be very useful as well as standardized procedures for performing in silico assessments.1,2 However, …
Continue reading “In silico toxicology assessments throughout the product life cycle”
The World Congress on Alternatives and Animal Use in the Life Sciences is where scientists from academia, industry, government, and the non-profit sector meet to advance the 3Rs—to reduce, refine, and replace the use of animals. This year the conference – WC12 – is being held at Niagara Falls in Canada.1 The conference is organized …
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 …
Continue reading “European Medicines Agency Provides Significant Update on N-nitrosamine Impurities”
Given the movement towards the use of alternatives to animal studies, there is a lot of new interest in in silico toxicological methods. While the ins and outs of in silico toxicology may be familiar to our typical readership, I would like to take a step back and provide foundational content to readers who may …
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 …
