A critical appraisal of the duration of chronic animal toxicity studies.
One method of assessing the contribution of studies of longer than 6 months to a safety evaluation program is to compare retrospectively the findings in toxicity tests carried out for 6 months or less with those observed after 6 months. The Centre for Medicines Research has therefore established a databank comprising animal toxicological data obtained from pharmaceutical companies in Europe. Twenty-one companies have provided data for 124 compounds (214 studies), including 88 studies of 65 compounds where comparable short-term (less than or equal to 6 months) and long-term (greater than 6 months) data are available. The results from the 88 studies show that, excluding the possibility of identifying carcinogens, tests of longer than 6 months have not added to the overall safety evaluation of these compounds.
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D000818:Animals; D004285:Dogs; D004341:Drug Evaluation; D004345:Drug Industry; D064420:Drug-Related Side Effects and Adverse Reactions; D005060:Europe; D006801:Humans; D051381:Rats; D012107:Research Design; D013045:Species Specificity; D013997:Time Factors