Over the last year we have been working hard developing a new easy-to-use read-across solution that can instantaneously access over 200,000 chemicals with over 600,000 toxicity studies. The platform is able to integrate this data with chemicals and studies added by the user to conduct a read-across evaluation. It has been designed to directly support …
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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 …
New in silico paper on acute toxicity
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 …
Neurotoxicity hazard assessment framework that integrates in silico approaches
Earlier this year, we described the results from a collaborative working group that developed a neurotoxicity hazard assessment framework that integrates in silico approaches1. This cross-industry collaboration resulted in a publication within a special issue of the Journal of Computational Toxicology2. Dr. Arianna Bassan will be presenting the project on July 22nd, 2022 at 9:00 …
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Novel application of in silico methods in the assessment of Extractables and Leachables
New therapeutic modalities play a critical role in our health and safety. Novel therapeutics may be comprised of biologically based molecules including peptides, monoclonal antibodies, and genetic materials. The quality and safety of these products can be assessed using experimental systems; however, it is important to ask whether in silico methods can add value to …
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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6-year anniversary of the ICH M7 principles and procedures publication
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 …
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