International Harmonization and Cooperation in the Validation of Alternative Methods.

Autor:	Barroso J; European Commission, Joint Research Centre (JRC), Ispra, Italy. joao.barroso@ec.europa.eu., Ahn IY; Toxicological Evaluation and Research Department, Korean Center for the Validation of Alternative Methods (KoCVAM), National Institute of Food and Drug Safety Evaluation, Cheongju-si, South Korea., Caldeira C; Brazilian Center for Validation of Alternative Methods (BraCVAM) and National Institute of Quality Control in Health (INCQS), Rio de Janeiro, Brazil., Carmichael PL; Unilever Safety and Environmental Assurance Centre, Colworth Science Park, Sharnbrook, Bedfordshire, UK., Casey W; Division of the National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, DC, USA.; Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), Washington, DC, USA., Coecke S; European Commission, Joint Research Centre (JRC), Ispra, Italy., Curren R; Institute for In Vitro Sciences, Inc., Gaithersburg, MD, USA., Desprez B; European Commission, Joint Research Centre (JRC), Ispra, Italy., Eskes C; Services and Consultation on Alternative Methods (SeCAM), Magliaso, Switzerland., Griesinger C; European Commission, Joint Research Centre (JRC), Ispra, Italy., Guo J; Evaluation and Research Centre for Toxicology, Institute of Disease Control and Prevention, Academy of Military Medical Sciences, Beijing, China., Hill E; Institute for In Vitro Sciences, Inc., Gaithersburg, MD, USA., Roi AJ; European Commission, Joint Research Centre (JRC), Ispra, Italy., Kojima H; Japanasese Center for the Validation of Alternative Methods (JaCVAM), National Institute of Health Sciences, Tokyo, Japan., Li J; Unilever Safety and Environmental Assurance Centre, Colworth Science Park, Sharnbrook, Bedfordshire, UK., Lim CH; Toxicological Evaluation and Research Department, Korean Center for the Validation of Alternative Methods (KoCVAM), National Institute of Food and Drug Safety Evaluation, Cheongju-si, South Korea., Moura W; Brazilian Center for Validation of Alternative Methods (BraCVAM) and National Institute of Quality Control in Health (INCQS), Rio de Janeiro, Brazil., Nishikawa A; Japanasese Center for the Validation of Alternative Methods (JaCVAM), National Institute of Health Sciences, Tokyo, Japan., Park H; Toxicological Evaluation and Research Department, Korean Center for the Validation of Alternative Methods (KoCVAM), National Institute of Food and Drug Safety Evaluation, Cheongju-si, South Korea., Peng S; Evaluation and Research Centre for Toxicology, Institute of Disease Control and Prevention, Academy of Military Medical Sciences, Beijing, China., Presgrave O; Brazilian Center for Validation of Alternative Methods (BraCVAM) and National Institute of Quality Control in Health (INCQS), Rio de Janeiro, Brazil., Singer T; Environmental Health Science and Research Bureau, Health Canada, Ottawa, Canada., Sohn SJ; Toxicological Evaluation and Research Department, Korean Center for the Validation of Alternative Methods (KoCVAM), National Institute of Food and Drug Safety Evaluation, Cheongju-si, South Korea., Westmoreland C; Unilever Safety and Environmental Assurance Centre, Colworth Science Park, Sharnbrook, Bedfordshire, UK., Whelan M; European Commission, Joint Research Centre (JRC), Ispra, Italy., Yang X; Guangdong Province Centre for Disease Control and Prevention, Guangzhou, China., Yang Y; Guangdong Province Centre for Disease Control and Prevention, Guangzhou, China., Zuang V; European Commission, Joint Research Centre (JRC), Ispra, Italy.
Jazyk:	angličtina
Zdroj:	Advances in experimental medicine and biology [Adv Exp Med Biol] 2016; Vol. 856, pp. 343-386.
DOI:	10.1007/978-3-319-33826-2_14
Abstrakt:	The development and validation of scientific alternatives to animal testing is important not only from an ethical perspective (implementation of 3Rs), but also to improve safety assessment decision making with the use of mechanistic information of higher relevance to humans. To be effective in these efforts, it is however imperative that validation centres, industry, regulatory bodies, academia and other interested parties ensure a strong international cooperation, cross-sector collaboration and intense communication in the design, execution, and peer review of validation studies. Such an approach is critical to achieve harmonized and more transparent approaches to method validation, peer-review and recommendation, which will ultimately expedite the international acceptance of valid alternative methods or strategies by regulatory authorities and their implementation and use by stakeholders. It also allows achieving greater efficiency and effectiveness by avoiding duplication of effort and leveraging limited resources. In view of achieving these goals, the International Cooperation on Alternative Test Methods (ICATM) was established in 2009 by validation centres from Europe, USA, Canada and Japan. ICATM was later joined by Korea in 2011 and currently also counts with Brazil and China as observers. This chapter describes the existing differences across world regions and major efforts carried out for achieving consistent international cooperation and harmonization in the validation and adoption of alternative approaches to animal testing.
Databáze:	MEDLINE
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