Value of shared preclinical safety studies – the eTOX database

A first analysis of a database of shared preclinical safety data donated by thirteen pharmaceutical organisations for the eTOX project is presented. Species, duration of exposure and administration route data were analysed to assess if large enough subsets of homogenous data are available for building in silico predictive models. The eTOX ontology was used to determine the most common treatment-related clinical chemistry and histopathology findings reported in the database. The data were then mined to evaluate sensitivity of established in vivo biomarkers for liver toxicity risk assessment. The value of the database for read-across approaches during early drug development is illustrated by a case study