One science-driven approach for the regulatory implementation of alternative methods: A multi-sector perspective.
Regul Toxicol Pharmacol
; 99: 33-49, 2018 Nov.
Article
em En
| MEDLINE
| ID: mdl-30098372
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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Indústrias
/
Alternativas aos Testes com Animais
Tipo de estudo:
Etiology_studies
/
Prognostic_studies
/
Risk_factors_studies
Aspecto:
Implementation_research
Limite:
Animals
/
Humans
País/Região como assunto:
Europa
Idioma:
En
Revista:
Regul Toxicol Pharmacol
Ano de publicação:
2018
Tipo de documento:
Article