Meeting report, ICH M7 relevant workshop: Use of (Q)SAR systems and expert judgment

Abstract

Use of Quantitative Structure-Activity Relationships ((Q)SAR) prediction tools has been increasing since the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) M7 guideline was issued in June 2014. The Japanese Environmental Mutagen Society and the Bacterial Mutagenicity Study Group took the initiative of the workshop on (Q)SAR in 2016 to discuss using (Q)SAR to predict mutagenicity. The aim of the workshop was to form a common understanding on the current use of (Q)SAR tools in industry and for regulatory purposes and on the process of expert judgment. This report summarizes the general session that reviewed the use of (Q)SAR tools and the case study session that discussed expert judgment.