Strategic focus on 3R principles reveals major reductions in the use of animals in pharmaceutical toxicity testing

PLoS ONE

Volumn 9, Issue 7, 2014, Pages

  Törnqvist, Elin ^a,b   Annas, Anita ^b   Granath, Britta ^b,c   Jalkesten, Elisabeth ^b,d   Cotgreave, Ian ^a,b,e   Öberg, Mattias ^a,e  

^a KAROLINSKA INSTITUTE   (Sweden)

^b ASTRAZENECA R AND D   (Sweden)

^c UNIVERSITY OF GOTHENBURG   (Sweden)

^d KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^e Swedish Toxicology Sciences Research Center   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

ANIMAL USE; ARTICLE; BREATHING DISORDER; COMPUTER MODEL; CONTROLLED STUDY; DOG; EMPLOYEE; HUMAN; IN VITRO STUDY; IN VIVO STUDY; MOUSE; NONHUMAN; PRACTICE GUIDELINE; PREGNANCY RATE; RABBIT; RAT; REPLACEMENT REDUCTION AND REFINEMENT; REPRODUCTIVE TOXICITY; RETROSPECTIVE STUDY; STUDY DESIGN; TOXICITY TESTING; ANIMAL; ANIMAL EXPERIMENT; ANIMAL TESTING ALTERNATIVE; ANIMAL WELFARE; COOPERATION; DRUG INDUSTRY; DRUG SCREENING; MEDICAL RESEARCH; METHODOLOGY; PROCEDURES; REPRODUCIBILITY; STANDARDS; TRENDS;

ANIMAL EXPERIMENTATION; ANIMAL TESTING ALTERNATIVES; ANIMAL WELFARE; ANIMALS; BIOMEDICAL RESEARCH; COOPERATIVE BEHAVIOR; DOGS; DRUG EVALUATION, PRECLINICAL; DRUG INDUSTRY; HUMANS; MICE; RABBITS; RATS; REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN; TOXICITY TESTS;

EID: 84904637119     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0101638     Document Type: Article

References (39)

1. Russell WMS, Burch RL (1959) The Principles of Humane Experimental Technique.
2. Zurlo J, Rudacille D, Goldberg AM (1996) The three Rs: the way forward. Environ Health Perspect 104: 878-880. (Pubitemid 26319290)
3. ATLA, Prepared by the Executive Committee of the Congress (2009) The Three Rs Declaration of Bologna, Adopted by the third World Congress on Alternative and Animal Use in the Life Sciences, Bologna, Italy, on 31 August 1999. Altern Lab Anim 37: 286-289.
4. European Union (2010) Directive 2010/63/EU of the Eurpean Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes. OJEU L 276/33.
5. Filipecki AT, Machado CJ, Valle S, Teixeira M (2011) The Brazilian legal framework on the scientific use of animals. Ilar J 52: E8-15.
6. Kurosawa TM (2007) Japanese Regulation of Laboratory Animal Care with 3Rs, Alternatives to Animal Testing and EXperimentation (AATEX), Special Issue: Proc. 6th World Congress on Alternatives & Animal Use in the Life Sciences. 14: 317-321.
7. Unitid States (2012) United States Code, 2012 Edition, Title 7 - agriculture, Chapter 54 - Transportation, Sale, and Handling of Certain Animals.
8. Kong Q, Qin C (2009) Analysis of current laboratory animal science policies and administration in China. Ilar J 51: e1-e11.
9. Pereira S, Veeraraghavan P, Ghosh S, Gandhi M (2004) Animal experimentation and ethics in India: the CPCSEA makes a difference. Altern Lab Anim 32 Suppl 1B: 411-415. (Pubitemid 38843418)
10. Pereira S, Tettamanti M (2005) Ahimsa and alternatives - the concept of the 4th R. The CPCSEA in India. Altex 22: 3-6. (Pubitemid 40392715)
11. OECD (2014) OECD Considers Animal Welfare in the Development of Test Guidelines. Available: http://www.oecd.org/env/ehs/testing/animalwelfare.htm. Accessed 2014 January 14.
12. European Union (2008a) Council regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). OJEU L 142/1.
13. European Union (2008b) Regulation No (EC) 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. OJEU L 353/1.
14. European Union (2009) Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. OJEU L 309/1.
15. European Union (2009b) Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. OJEU L 342/59.
16. Ohno Y (2002) ICH Guidelines - Implementation of the 3Rs (Refinement, Reduction, and Replacement): Incorporating Best Scientific Practices into the Regulatory Process. Institute for Laboratory Animal Research J. 43 (Suppl 1): S95-S98.
17. The Canadian Council on Animal Care (2014) Available at: http://ccac.ca/en-/about Accessed: 2014 January 14.
18. The Australian and New Zealand Council for the Care of Animals in Research and Teaching Ltd (2014) Available: http://www.adelaide.edu.au/ANZCCART/ about/. Accessed 2014 January 14.
19. The National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) (2014) Available: http://www.nc3rs.org.uk/. Accessed 2014 January 14.
20. Finnish Natioanl Consensus Platform for Alternatives (2014). Available: http://jarjestot.uta.fi/fincopa/. Accessed 2014 January 14.
21. Netherlands Knowledge Centre on Alternatives to animal use, NKCA (2014) Available: http://www.nkca.nl/algemeen/menu/english/. Accessed 2014 January 14.
22. Fenwick N, Danielson P, Griffin G (2011) Survey of Canadian animal-based researchers' views on the Three Rs: replacement, reduction and refinement. PLoS One 6: e22478.
23. Houde L, Dumas C, Leroux T (2009) Ethics: views from IACUC members. Altern Lab Anim 37: 291-296.
24. BIS (2012) Views on the use of animals in scientific research. Dept. for Business, Innovation and Skills, Ipsos MORI/12-017292.
25. Ormandy EH, Schuppli CA, Weary DM (2009) Worldwide trends in the use of animals in research: the contribution of genetically-modified animal models. Altern Lab Anim 37: 63-68.
26. van Luijk J, Leenaars M, van Dongen, AM, van der Vaart L, Ritskes-Hoitinga M (2012) Outcomes of a Dutch workshop on improvements for the 3Rs in daily practice. Altex 29: 440-443.
27. Flecknell P (2002) Replacement, reduction and refinement. Altex 19: 73-78.
28. European Commission (2013) Seventh Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union, COM(2013) 859 final.
29. Akbarsha MA, Zeeshan M, Pereira S (2012) Alternatives discussed at Indian Science Congress. Altex 29: 216-218.
30. SEURAT-1. (2014) Safety Evaluation Ultimately Replacing Animal Testing (SEURAT). Available: http://www.seurat-1.eu/. Accessed 2014 January 14.
31. Brönstad A, Berg AG (2011) The role of organizational culture in compliance with the principles of the 3Rs. Lab Anim (NY) 40: 22-26.
32. Schuppli CA, Fraser D (2005) The interpretation and application of the three Rs by animal ethics committee members. Altern Lab Anim 33: 487-500. (Pubitemid 41608020)
33. Jonsson O, Villar R, Nilsson LB, Norsten-Höög C, Brogren J, et al. (2012a) Capillary microsampling of 25 ml blood for the determination of toxicokinetic parameters in regulatory studies in animals. Bioanalysis 4: 661-674.
34. Jonsson O, Villar R, Nilsson LB, Eriksson M. Königsson K (2012b) Validation of a bioanalytical method using capillary microsampling of 8 μl plasma samples: application to a toxicokinetic study in mice. Bioanalysis 4: 1989-1998.
35. Annys E, Billington R, Clayton R, Bremm KD, Graziano M, et al. (2014) Advancing the 3Rs in regulatory toxicology - carcinogenicity testing: Scope for harmonization and advancing the 3Rs in regulated sectors of the European Union. Regul Toxicol Pharmacol 69: 234-242.
36. Verbost PM, van der Valk J, Hendriksen CF (2007) Effects of the introduction of in vitro assays on the use of experimental animals in pharmacological research. Altern Lab Anim 35: 223-228. (Pubitemid 46883162)
37. Robinson S, Delongeas JL, Donald E, Dreher D, Festag M, et al. (2008) A European pharmaceutical company initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development. Regul Toxicol Pharmacol 50: 345-352.
38. Creton S, Weltje L, Hobson H, Wheeler JR (2013) Reducing the number of fish in bioconcentration studies for plant protection products by reducing the number of test concentrations. Chemosphere 90: 1300-1304.
39. European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM) (2014) Available: http://ihcp.jrc.ec.europa.eu/our-labs/eurl-ecvam. Accessed 2014 January 14.