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|Title:||One science-driven approach for the regulatory implementation of alternative methods: A multi-sector perspective|
|Authors:||DAL NEGRO GIANNI; ESKES CHANTRA; BELZ SUSANNE; BERTEIN CAROLINE; CHLEBUS MAGDA; CORVARO MARCO; CORVI RAFFAELLA; DHALLUIN STEPHANE; HALDER MARIA ELISABETH; HARVEY JAMES; HERMANN MARTINA; HOFFMANN-DÖRR SIMONE; KILIAN KARIN; LAMBRIGTS DENIS; LAROCHE CHARLES; LOUHIMIES SUSANNA; MAHONY CATHERINE; MANOU IRENE; MCNAMEE PAULINE; PRIETO PERAITA MARIA DEL PILAR; REID KIRSTY; ROGGEN ERWIN; SCHUTTE KATRIN; STIRLING CATRINA; UHLRICH SYLVIE; WEISSENHORN RENATE; WHELAN MAURICE|
|Citation:||REGULATORY TOXICOLOGY AND PHARMACOLOGY vol. 99 p. 33-49|
|Publisher:||ACADEMIC PRESS INC ELSEVIER SCIENCE|
|Type:||Articles in periodicals and books|
|Abstract:||EU regulations call for the use of alternative methods to animal testing. During the last decade, an increasing number of alternative approaches have been formally adopted. In parallel, new 3Rs-relevant technologies and mechanistic approaches have increasingly contributed to hazard identification and risk assessment evolution. In this changing landscape, an EPAA meeting reviewed the challenges that different industry sectors face in the implementation of alternative methods following a science-driven approach. Although clear progress was acknowledged in animal testing reduction and refinement thanks to an integration of scientifically robust approaches, the following challenges were identified: i) further characterization of toxicity pathways; ii) development of assays covering current scientific gaps, iii) better characterization of links between in vitro readouts and outcome in the target species; iv) better definition of alternative method applicability domains, and v) appropriate implementation of the available approaches. For areas having regulatory adopted alternative methods (e.g., vaccine batch testing), harmonised acceptance across geographical regions was considered critical for broader application. Overall, the main constraints to the application of non-animal alternatives are the still existing gaps in scientific knowledge and technological limitations. The science-driven identification of most appropriate methods is key for furthering a multi-sectorial decrease in animal testing.|
|JRC Directorate:||Health, Consumers and Reference Materials|
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