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Finding synergies for the 3Rs – Repeated dose toxicity testing: Report from an EPAA partners' forum

Laroche, C, Annys, E, Bender, H, Botelho, D, Botham, P, Brendler-Schwaab, S, Clayton, R, Corvaro, M, Dal Negro, G, Delannois, F, Dent, M, Desaintes, C, Desprez, B, Dhalluin, S, Hartmann, A, Hoffmann-Doerr, S, Hubesch, B, Irizar, A, Manou, I, Müller, BP , Nadzialek, S, Prieto, P, Rasenberg, M, Roggeband, R, Rowan, TG, Schutte, K, van de Water, B, Westmoreland, C, Whelan, M, Wilschut, A, Zvonimir, Z and Cronin, MTD (2019) Finding synergies for the 3Rs – Repeated dose toxicity testing: Report from an EPAA partners' forum. Regulatory Toxicology and Pharmacology. ISSN 0273-2300

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Abstract

The European Partnership for Alternative Approaches to Animal Testing (EPAA) convened a Partners' Forum on repeated dose toxicity (RDT) testing to identify synergies between industrial sectors and stakeholders along with opportunities to progress these in existing research frameworks. Although RTD testing is not performed across all industrial sectors, the OECD accepted tests can provide a rich source of information and play a pivotal role for safety decisions relating to the use of chemicals. Currently there are no validated alternatives to repeated dose testing and a direct one-to-one replacement is not appropriate. However, there are many projects and initiatives at the international level which aim to implement various aspects of replacement, reduction and refinement (the 3Rs) in RDT testing. Improved definition of use, through better problem formulation, aligned to harmonisation of regulations is a key area, as is the more rapid implementation of alternatives into the legislative framework. Existing test designs can be optimised to reduce animal use and increase information content. Greater use of exposure-led decisions and improvements in dose selection will be beneficial. In addition, EPAA facilitates sharing of case studies demonstrating the use of Next Generation Risk Assessment applying various New Approach Methodologies to assess RDT.

Item Type: Article
Uncontrolled Keywords: 1115 Pharmacology and Pharmaceutical Sciences
Subjects: R Medicine > RM Therapeutics. Pharmacology
Divisions: Pharmacy & Biomolecular Sciences
Publisher: Elsevier BV
Date Deposited: 04 Sep 2019 08:33
Last Modified: 04 Sep 2019 08:33
DOI or Identification number: 10.1016/j.yrtph.2019.104470
URI: http://researchonline.ljmu.ac.uk/id/eprint/11270

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