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 …
Tag archives: (Q)SAR
FDA Modernization Act 2.0
The U.S. Congress recently passed the FDA Modernization Act 2.01 which permits the use of alternatives to animal studies as part of the FDA’s regulatory approval process. The new legislation explicitly identifies in silico models as one of these alternatives. This legislation is an important step forward in the use of alternative methods and will …
The Use of Artificial Intelligence to Support Safety Predictions
Last year, we were happy to contribute to a new book describing the use of both supervised and unsupervised machine learning approaches to support the prediction of toxicity and is illustrated with case studies related to regulatory submissions. The book chapter emphasized the importance of high-quality databases, containing toxicology and chemistry information. Such comprehensive databases …
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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 …
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Acute Toxicity in silico Battery
We are happy to have completed, after many years of work, a full battery of in silico models to evaluate acute toxicity. These models predict acute lethality by three routes of exposure (oral, dermal, inhalation), as well as skin and eye irritation/corrosion, and skin sensitization. They aim to support a variety of applications, including health, …
ELSIE Webinar on a Framework for Sensitization Assessment for E&L and Practical Application
We are delighted to be participating in an upcoming webinar organized by the Extractables and Leachables Safety Information Exchange (ELSIE) Consortium on the topic of a framework for sensitization assessment for Extractables and Leachables (E&L) on 22 September 2022, 9:30 – 11:00 AM ET1. We will be describing the development of a representative database of …
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 …
Publication of the special issue of computational toxicology on the in silico toxicology protocol initiative
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 …
The Leadscope bacterial mutagenicity expert alerts journey to universal regulatory acceptance
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 …
Special issue of the Journal of Computational Toxicology
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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