In Silico Insider

Information for Computational Toxicologists

Welcome to In Silico Insider, a bi-weekly info-Blog that you’ll surely want to bookmark.

We invite you to step inside our online community, where our subject matter experts will share important insights about key issues facing our industry. From regulatory updates to industry innovations and scientific best practice, we hope this becomes a regular destination for you.

Instem at QSAR 2021

QSAR 20211 is around the corner and after last year’s cancellation, we are excited to be in attendance. We are pleased to be contributors to this year’s program through participation in two platform sessions in addition to poster presentations. If you are a frequent reader of this blog, you have read about our work on …

Cross-industry development of structural alerts to support the FDA Guidance on in vitro drug interaction studies

A recent FDA guidance for industry, titled “In Vitro Drug Interaction Studies – Cytochrome P450 Enzyme- and Transporter- Mediated Drug Interactions”1 includes the following statement:  “A lower cut-off value for the metabolite-to-parent AUC ratio may also be considered for metabolites with structural alerts for potential mechanism-based inhibition (Orr, 2012; Yu, 2013; Yu, 2015)” Today, a …

New book on Mutagenic Impurities

We have been really happy to contribute to a number of chapters in an important new book edited by Dr. Andrew Teasdale: “Mutagenic Impurities: Strategies for Identification and Control”1 This will be an essential read for students and professionals in the field of genotoxic impurities (GTIs) assessment covering topics including a history of the regulatory …