Assessing whether In Silico models are fit-for-purpose

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 …

In silico toxicology assessments throughout the product life cycle

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, …

World Congress on Alternatives

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 …

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 …

Target carcinogenicity assessment

The recently introduced ICH S1B addendum1 (integrated with the original S1B guideline on 4th August 2022) includes a new weight of evidence (WoE) assessment to determine whether performing a 2-year rat study would add value to the assessment of human carcinogenic risk. The guideline describes six WoE factors – [1] target biology, [2] secondary pharmacology, [3] …