Four papers accepted for publication

Over the last couple of weeks, we have received news that four papers, submitted earlier this year to the Journal of Computational Toxicology, have been accepted for publication. Developing Structure-Activity Relationships for N-Nitrosamine Activity1 This paper outlines N-Nitrosamine carcinogenic potency ranges and describes specific structural features that have clear effects on these ranges. It highlights …

US FDA collaborations – predicting mutagenicity and beyond…

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. Over the last 15 years I have been working closely with the US Food and Drug Administration (FDA) as a principal investigator on …

Expanding the use of in silico toxicology

The application of in silico toxicology is constantly increasing as we better understand how such methods can support different applications (such as the assessment of genotoxic impurity, extractables and leachables, chemicals requiring classification and labelling, and so on). Position papers are critical to support this expansion. We have reported in some recent blog posts progress …

Why is it important to define confidence?

As Candice described in her recent blog “So many pieces of information!” – making actionable decisions is extremely complicated, especially when integrating the results from in silico models alongside historical in vivo studies and in vitro experiments. When is there sufficient information to make a decision? Well, it depends the type of decision and the …

Can the burden on industry and regulators be reduced?

About 6 years ago, the International Conference on Harmonization (ICH) published the M7 guideline “Assessment and Control of DNA reactive (mutagenic) Impurities in Pharmaceuticals to limit Potential Carcinogenic Risk”.[1] This was a landmark moment for computational toxicology, as it was the first time such methods were recognized by the ICH as a regulatory test. An …