| Validation of Alternative Methods for Toxicity Testing Leon H. Bruner,1 Gregory J. Carr,2 Rodger D. Curren,3 and Mark Chamberlain4 1The Procter & Gamble Company, Health and Beauty Care Europe, Staines, Middlesex, United Kingdom; 2The Procter & Gamble Company, Miami Valley Laboratories, Cincinnati, Ohio; 3Microbiological Associates, Incorporated, Institute for In Vitro Sciences, Gaithersburg, Maryland; 4Unilever Research, Environmental Safety Laboratory, Sharnbrook, Bedford, United Kingdom Abstract
Before nonanimal toxicity tests may be officially accepted by regulatory agencies, it is generally agreed that the validity of the new methods must be demonstrated in an independent, scientifically sound validation program. Validation has been defined as the demonstration of the reliability and relevance of a test method for a particular purpose. This paper provides a brief review of the development of the theoretical aspects of the validation process and updates current thinking about objectively testing the performance of an alternative method in a validation study. Validation of alternative methods for eye irritation testing is a specific example illustrating important concepts. Although discussion focuses on the validation of alternative methods intended to replace current in vivo toxicity tests, the procedures can be used to assess the performance of alternative methods intended for other uses. -- Environ Health Perspect 106(Suppl 2) :477-484 (1998) . http://ehpnet1.niehs.nih.gov/docs/1998/Suppl-2/477-484bruner/abstract.html Key words: validation, alternative methods, prediction model, reliability, relevance, eye irritation testing
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