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 …
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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”
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 …
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(Q) SAR and veterinary medical products
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 …
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 …
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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 …
Continue reading “Computational toxicology 2022 year-end review”
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 …
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”
