© 1998 Oxford University Press
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Workshop Overview: Scientific and Regulatory Challenges for the Reduction, Refinement, and Replacement of Animals in Toxicity Testing1
*Central Toxicology Laboratory, Zeneca Ltd. Alderley Park, Macclesfield, Cheshire SK10 4TJ, United Kingdom
The Procter and Gamble Company, Health and Beauty Care Europe Staines, Middlesex TW18 3AZ, United Kingdom
Bristol-Myers Squibb Company, Experimental Pathology 6000 Thompson Road, Building 32A, East Syracuse, New York 13057-5050
§Armstrong Laboratory, US Air Force L AL HSC/OET, 2856 G Street, Building 79, Wright Patterson AFB, Ohio 45433-7400
¶NTP Interagency Center for the Evaluation of Alternative Toxicological Methods Environmental Toxicology Program, NIEHS, MD WC-05, P.O. Box 12233, Research Triangle Park, North Carolina 27709-12233
Received February 19, 1998; accepted February 23, 1998
Public concern for animal welfare has been expressed through legislative control of animal use for experimental purposes since the first legislation was introduced in 1876 in the United Kingdom. Legislative control of animal use has been introduced in virtually every developed country, with major initiatives in Europe (1986) and the United States (1966 and 1985). Advances in scientific thinking resulted in the development of the concept of the three Rs—refinement, reduction, and replacement—by Russell and Burch in 1959. The field has expanded substantially since, with specialist scientific journals dedicated to alternatives, World Congresses organized to discuss the scientific and philosophical issues, and European and U.S. validation organizations being launched. Current scientific attention is focused on validation of alternative methods. The underlying scientific principles of chemical toxicity are complicated and insufficiently understood for alternative methods for all toxicity endpoints of importance in protecting human health to be available. Important lessons have been learned about how to validate methods, including the need to have prediction models available before the validation is undertaken, the need to understand the variability of the animal-based data which is to be used as the validation standard, and the need to have well-managed validation programs. Future progress will depend on the development of novel methods, which can now be validated through international collaborative efforts.
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