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 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”
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 …
In 2016, we initiated a new project to develop a standardized procedure for in silico experts performing assessments, similar to in vitro or in vivo test guidelines. This would streamline the application of in silico methods, ensure best practices are adopted, and defend its use to colleagues, peers, and regulators. The general framework paper1 was …
We are pleased to announce the publication of a new paper “Principles and Procedures for Assessment of Acute Toxicity Incorporating In Silico Methods”.1 This paper presents the results from a significant cross-industry collaboration to support the application of in silico methods for (1) product research and development, (2) product approval and registration as well as …
A special issue of the Journal of Computational Toxicology on the in silico toxicology protocol initiative1 is currently being finalized. Myself (Glenn Myatt), Kevin Cross and Candice Johnson from Instem were happy to support this effort as guest editors and many of the articles are already available on-line. The in silico toxicology protocol initiative was …
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This week we are pleased to welcome Dr. Kevin Crofton and Dr. Arianna Bassan as guest contributors to the blog. Within the in silico toxicology project, a position paper on neurotoxicity is appearing in a special issue of the journal of Computational Toxicology1. This paper discusses the need for the development of more informative new …
Continue reading “Neurotoxicity hazard assessment framework that integrates in silico approaches”
This week we are pleased to welcome Dr. Arianna Bassan as a guest contributor to the blog. The recently published draft addendum of the ICH S1B guideline1 introduces a weight-of-evidence (WoE) approach to assess human carcinogenic potential of small molecule pharmaceuticals and determine whether a 2-year rat carcinogenicity study would add value. Application of this …
The in silico toxicology project objective is to support the acceptance and implementation of in silico toxicology through working groups and publications covering: (1) protocols, (2) position papers, (3) case studies, (4) fit-for-purpose evaluations, and (5) structure-activity relationships. As we look back at 2021, it’s been another great year of progress. So far this year, …
