Value of shared preclinical safety studies – The eTOX database
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- dc.contributor.author Briggs, Katharine
- dc.contributor.author Barber, Chris
- dc.contributor.author Cases, Montserrat
- dc.contributor.author Marc, Philippe
- dc.contributor.author Steger-Hartmann, Thomas
- dc.date.accessioned 2023-11-20T08:26:45Z
- dc.date.available 2023-11-20T08:26:45Z
- dc.date.issued 2015
- dc.description.abstract A first analysis of a database of shared preclinical safety data for 1214 small molecule drugs and drug candidates extracted from 3970 reports donated by thirteen pharmaceutical companies for the eTOX project (www.etoxproject.eu) 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. Prevalence of treatment related effects for the different types of findings recorded were analysed. 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 to inform other drug development projects during early drug development is illustrated by a case study.
- dc.description.sponsorship The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n°115002, resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution. The authors would like to formally acknowledge the contribution to the eTOX project of all scientists and other staff involved.
- dc.format.mimetype application/pdf
- dc.identifier.citation Briggs K, Barber C, Cases M, Marc P, Steger-Hartmann T. Value of shared preclinical safety studies – The eTOX database. Toxicology Reports. 2015;2:210-21. DOI: 10.1016/j.toxrep.2014.12.004
- dc.identifier.doi http://dx.doi.org/10.1016/j.toxrep.2014.12.004
- dc.identifier.issn 2214-7500
- dc.identifier.uri http://hdl.handle.net/10230/58314
- dc.language.iso eng
- dc.publisher Elsevier
- dc.relation.ispartof Toxicology Reports. 2015;2:210-21
- dc.relation.projectID info:eu-repo/grantAgreement/EC/FP7/115002
- dc.rights © 2014 The Authors. Published by Elsevier Ireland Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/3.0/).
- dc.rights.accessRights info:eu-repo/semantics/openAccess
- dc.rights.uri http://creativecommons.org/licenses/by/3.0/
- dc.subject.keyword Data sharing
- dc.subject.keyword Toxicology
- dc.subject.keyword Data mining
- dc.subject.keyword Biomarkers
- dc.subject.keyword Ontology
- dc.title Value of shared preclinical safety studies – The eTOX database
- dc.type info:eu-repo/semantics/article
- dc.type.version info:eu-repo/semantics/publishedVersion