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.

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 …

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 …