Angela White

TL;DR: The publication presents a novel approach for determining the reliability of in silico predictions alongside experimental data and discusses how to determine the level of confidence in the assessment based on the relevance and reliability of the information.

TL;DR: The procedures presented here for structure-based assessment are considered appropriate for regulatory submissions in the scope of ICH M7 and a rule-based expert system complemented by either expert knowledge or a second (Q)SAR model is appropriate.

TL;DR: Results indicate that rapid assessment of genotoxicity can be accomplished with a relatively simple flow cytometric technique, and that the scoring system is transferable across laboratories, and may help reduce the occurrence of irrelevant positive results.

TL;DR: This paper outlines a series of principles and procedures to consider when generating (Q)SAR assessments aligned with the ICH M7 guideline to be included in a regulatory submission.

TL;DR: To assess how confident the authors can be in identifying non-mutagenic structures, eight companies were surveyed and the Negative Predictive Value (NPV) of the in silico approaches was 94%.