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 …

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 …

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 …

Neurotoxicity hazard assessment framework that integrates in silico approaches

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 …

New book on mutagenic impurities

We were delighted to contribute to a new book on Mutagenic Impurities, edited by Andrew Teasdale – “Mutagenic Impurities: Strategies for Identification and Control”.1 The book incorporates a discussion on the ICH M7 guideline and covers the in silico assessment of mutagenicity, including the use of structure-activity relationship methodologies, to support the evaluation of impurities. …

Predicting the 6-pack

The 6-pack provides information on health hazards from short-term exposure to a test substance. It is a battery of in vivo tests that evaluate 1) acute systemic toxicity by different routes of exposure (i.e., oral, inhalation and dermal); 2) skin and eye irritation/corrosion; 3) dermal sensitization. It is used in the assessment of many products …

In silico toxicology project 2021 review

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, …