|
|||||
|
|
Opportunities to minimise animal use in pharmaceutical regulatory general toxicology: a cross-company review |
|
| Authors: | Sparrow Susan S Robinson Sally Bolam Sue Bruce Christopher Danks Andy Everett David Fulcher Stephen Hill Rose E Palmer Helen Scott Elspeth W Chapman Kathryn L |
| Affiliation: | aGlaxoSmithKline, Park Road, Ware, Herts SG12 0DP, UK;bAstraZeneca R&D, Alderley Park, Mereside, Alderley Park, Macclesfield, Cheshire SK10 4TG, UK;cCovance (Formerly Sanofi Aventis), Alnwick Research Centre, Willowburn Avenue, Alnwick, Northumberland NE66 2JH, UK;dPfizer Global Research and Development, Ramsgate Road, Sandwich, Kent CT13 9NJ, UK;eCharles River Laboratories, Elphinstone Research Centre, Tranent, Edinburgh EH33 2NE, UK;fCovance, Otley Road, Harrogate HG3 1PY, UK;gHarlan Laboratories Ltd., Shardlow Business Park, London Road, Shardlow, Derbyshire DE72 2GD, UK;hSequani Limited, Bromyard Road, Ledbury, Herefordshire HR8 1LH, UK;iHuntingdon Life Sciences, Woolley Road, Alconbury, Huntingdon, Cambridgeshire PE28 4HS, UK;jPentlands Management Systems Ltd., Midlothian Innovation Centre, Pentlandfield, Roslin, Midlothian EH25 9RE, UK;kNational Centre for Replacement, Refinement and Reduction of Animals in Research, Gibbs Building, 215 Euston Road, London NW1 2BE, UK |
| Abstract: | Toxicity studies in animals are carried out to identify the intrinsic hazard of a substance to support risk assessment for humans. In order to identify opportunities to minimise animal use in regulatory toxicology studies, a review of current study designs was carried out. Pharmaceutical companies and contract research organisations in the UK shared data and experience of standard toxicology studies (ranging from one to nine months duration) in rodents and non-rodents; and carcinogenicity studies in the rat and mouse. The data show that variation in study designs was primarily due to (i) the number of animals used in the main study groups, (ii) the use of animals in toxicokinetic (TK) satellite groups, and (iii) the use of animals in off-treatment recovery groups. The information has been used to propose a series of experimental designs where small adjustments could reduce animal use in practice, while maintaining the scientific objectives. |
| Keywords: | Animal numbers Toxicokinetics Regulatory toxicology Pharmaceuticals Study design Group size |
| 本文献已被 ScienceDirect PubMed 等数据库收录！ | |