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DOI10.1016/j.yrtph.2014.04.009
Advancing the 3Rs in regulatory toxicology - Carcinogenicity testing: Scope for harmonisation and advancing the 3Rs in regulated sectors of the European Union
Annys, Erwin1; Billington, Richard2; Clayton, Rick3; Bremm, Klaus-Dieter4; Graziano, Michael5; McKelvie, Jo6; Ragan, Ian7; Schwarz, Michael8; van der Laan, Jan Willem9; Wood, Charles10; Oberg, Mattias11; Wester, Piet12; Woodward, Kevin N.13
发表日期2014-07-01
ISSN0273-2300
卷号69期号:2页码:234-242
英文摘要

Different government agencies operating in the European Union regulate different types of chemical products but all require testing for carcinogenicity to support applications for product marketing and commercialisation. A conference was held in Brussels in 2013 where representatives of the pharmaceutical, animal health, chemical and plant protection industries, together with representatives of regulatory agencies, universities and other stakeholders, met under the auspices of The European Partnership for Alternative Approaches to Animal Testing (EPAA) to discuss the varying requirements for carcinogenicity testing, and how these studies might be refined to improve hazard evaluation and risk assessment while implementing principles of the 3Rs (replacement, refinement and reduction in animal studies). While there are some similarities, the regulatory approaches in pharmaceutical, animal health, chemical and plant protection sectors have varying degrees of flexibility in requirements for carcinogenicity testing, to an extent reflecting concerns over the magnitude and duration of human exposure, either directly as in therapeutic exposure to pharmaceuticals, or indirectly through the ingestion of residues of veterinary drugs or plant protection chemicals. The article discusses these differences and other considerations for modified carcinogenicity testing paradigms on the basis of scientific and 3Rs approaches. (C) 2014 Elsevier Inc. All rights reserved.


英文关键词Carcinogenicity;Pharmaceuticals;Veterinary drugs;Chemicals;Plant protection;Genotoxicity;Reduction;Replacement;Refinement;Transgenic
语种英语
WOS记录号WOS:000337069800010
来源期刊REGULATORY TOXICOLOGY AND PHARMACOLOGY
来源机构美国环保署
文献类型期刊论文
条目标识符http://gcip.llas.ac.cn/handle/2XKMVOVA/61752
作者单位1.CEFIC, Brussels, Belgium;
2.Dow AgroSci, Abingdon, Oxon, England;
3.IFAH Europe, Brussels, Belgium;
4.Bayer Pharma AG, Wuppertal, Germany;
5.Bristol Myers Squibb, Princeton, NJ USA;
6.Evita Serv, Craigavon, North Ireland;
7.European Partnership Alternat Anim Testing EPAA, Brussels, Belgium;
8.Univ Tubingen, Tubingen, Germany;
9.Med Evaluat Board, Utrecht, Netherlands;
10.Environm Protect Agcy, Res Triangle Pk, NC USA;
11.Karolinska Inst, Inst Environm Med, S-10401 Stockholm, Sweden;
12.RIVM, Bilthoven, Netherlands;
13.TSGE Consulting Ltd Knaresborough, Harrogate, England
推荐引用方式
GB/T 7714
Annys, Erwin,Billington, Richard,Clayton, Rick,et al. Advancing the 3Rs in regulatory toxicology - Carcinogenicity testing: Scope for harmonisation and advancing the 3Rs in regulated sectors of the European Union[J]. 美国环保署,2014,69(2):234-242.
APA Annys, Erwin.,Billington, Richard.,Clayton, Rick.,Bremm, Klaus-Dieter.,Graziano, Michael.,...&Woodward, Kevin N..(2014).Advancing the 3Rs in regulatory toxicology - Carcinogenicity testing: Scope for harmonisation and advancing the 3Rs in regulated sectors of the European Union.REGULATORY TOXICOLOGY AND PHARMACOLOGY,69(2),234-242.
MLA Annys, Erwin,et al."Advancing the 3Rs in regulatory toxicology - Carcinogenicity testing: Scope for harmonisation and advancing the 3Rs in regulated sectors of the European Union".REGULATORY TOXICOLOGY AND PHARMACOLOGY 69.2(2014):234-242.
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