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Prospects for reducing and refining the use of dogs in the regulatory toxicity testing of pharmaceuticals

Fund for the Replacement of Animals in Medical Experiments (FRAME), 96-98 North Sherwood Street, Nottingham NG1 4EE, UK

G Betton

AstraZeneca Pharmaceuticals, Alderley Park, Macclesfield SK10 4TF, UK

R Combes

Fund for the Replacement of Animals in Medical Experiments (FRAME), 96-98 North Sherwood Street, Nottingham NG1 4EE, UK

S Damment

GlaxoWellcome Research and Development, Park Road, Ware SG12 ODP, UK

D Everett

Covance Laboratories Limited, Otley Road, Harrogate HG3 1PY, UK

C Garner

CBAMS Ltd., Sandhutton, York Y04 1LZ, UK

Z Godsafe

SmithKline Beecham Pharmaceuticals, The Frythe, Welwyn Garden City AL6 9AR, UK

G Healing

AstraZeneca R&D Charnwood, Bakewell Road, Loughborough LE1 1 5RH, UK

R Heywood

M Jennings

Royal Society for the Prevention of Cruelty to Animals (RSPCA), The Causeway, Horsham RPH12 1HG, UK

C Lumley

CMR International, Novellus Court, 61 South Street, Epsom KT18 7PX, UK

G Oliver

AstraZeneca Pharmaceuticals, Alderley Park, Macclesfield SK10 4TF, UK

D Smith

AstraZeneca R&D Charnwood, Bakewell Road, Loughborough LE1 1 5RH, UK

D Straughan

Fund for the Replacement of Animals in Medical Experiments (FRAME), 96-98 North Sherwood Street, Nottingham NG1 4EE, UK

J Topham

R Wallis

Pfizer Central Research, Sandwich CT13 9NJ, UK

S Wilson

Inveresk Research International, Tranent, Edinburgh EH33 2NE, UK

P Buckley

Home OJfice, Room 431, Horseferry House, Dean Ryle Street, London SWiP 2AW, UK

A workshop was held to critically discuss the need for a non-rodent species and the role of the dog in regulatory toxicity testing of pharmaceuticals; to discuss opportunities to reduce and refine the use of dogs in preclinical toxicology; and to identify a number of specific recommendations which could be feasibly achieved to move the process forward. To facilitate a preliminary evaluation of the contribution of dog studies to the risk assessment process, anonymised, unpublished data were provided from fully evaluated, repeat dose toxicity studies in the rat and dog. Results ofthe International Life Sciences Institute (ILSI) Human Toxicity Project were also presented and discussed. Analysis of the data demonstrated that the dog can provide additional toxicity information, which, in some cases, was shown to be predictive for humans. Discussions indicated that there is potential for achieving a reduction in dog use and several possible approaches were identified. To further the progress of this initiative, there is a need to collate the results of pharmacology, toxicology, and clinical studies to address some of the proposed approaches. One of the outcomes of the workshop will be the establishment of a steering group to co-ordinate data collation for further analysis.

Key Words: dog • regulatory toxicology • reduction • refinement • three Rs • pharmaceutical

Human & Experimental Toxicology, Vol. 19, No. 8, 440-447 (2000)
DOI: 10.1191/096032700682694242


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