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Legacy data sharing to improve drug safety assessment: the eTOX project

Sanz, F and Pognan, F and Steger-Hartmann, T and Diaz, C and Cases, M and Pastor`, M and Marc, P and Wichard, J and Briggs, K and Watson, D and Kleinöder,, T and Yang, C and Amberg, A and Beaumont, M and Brookes, AJ and Brunak, S and Cronin, MTD and Ecker, GF and Escher, S and Greene, N and Guzman, A and Hersey, A and Jacques, P and Lammens, L and Mestres, J and Muster, W and Northeved, H and Pinches, M and Saiz, J and Sajot, N and Valencia, A and van der Lei, J and Vermeulen, NPE and Vock, E and Wolber, G and Zamora, I Legacy data sharing to improve drug safety assessment: the eTOX project. Nature Reviews Drug Discovery. ISSN 1474-1776 (Accepted)

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Abstract

Non-clinical safety assessment is often faced with the challenge of assessing candidate compounds with no or insufficient experimental data. Whereas relevant databases and reliable in silico tools exist for mutagenicity prediction, analogous resources for identifying potential organ toxicities are not as common or well developed. Scientists, therefore, have to resort to suboptimal procedures such as literature search and personal experience with similar compounds or classes. In parallel, there is a wealth of relevant data buried in the archives of the pharmaceutical industry that has not yet been leveraged. These data mainly exist in paper or pdf formats and, consequently, are difficult to search and analyze. In order to overcome these limitations and advance early safety assessment, 13 pharmaceutical companies, 11 academic partners and 6 small and medium-sized enterprises (SMEs) joined forces in the eTOX project, which started in January 2010 under the sponsorship of the European Innovative Medicines Initiative (IMI). Since the availability of a wide and representative collection of historical data is fundamental for generating reliable predictions, the main goals of the eTOX project were (i) to build a shared and mineable database containing a broad and relevant collection of data, constituted mainly by repeat-dose toxicity studies contributed by the pharmaceutical companies participating in the project, and (ii) to use the database and other sources of information for enabling more effective read-across and predictive modeling of safety endpoints.

Item Type: Article
Uncontrolled Keywords: 11 Medical And Health Sciences, 06 Biological Sciences
Subjects: R Medicine > RA Public aspects of medicine > RA1190 Toxicology. Poisions
R Medicine > RM Therapeutics. Pharmacology
Divisions: Pharmacy & Biomolecular Sciences
Publisher: Nature Publishing Group
Date Deposited: 25 Sep 2017 10:51
Last Modified: 25 Sep 2017 10:51
URI: http://researchonline.ljmu.ac.uk/id/eprint/7184

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