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 d...
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| Veröffentlicht in: | Regul. Toxicol. Pharmacol.; (United States) 1986-03, Vol.6 (1), p.66-72 |
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| container_title | Regul. Toxicol. Pharmacol.; (United States) |
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| creator | Lumley, Cynthia E. Walker, Stuart R. |
| description | 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 (⩽6 months) and long-term (>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. |
| doi_str_mv | 10.1016/0273-2300(86)90040-1 |
| format | Article |
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Toxicol. Pharmacol.; (United States)</title><addtitle>Regul Toxicol Pharmacol</addtitle><description>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 (⩽6 months) and long-term (>6 months) data are available. 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| ispartof | Regul. Toxicol. Pharmacol.; (United States), 1986-03, Vol.6 (1), p.66-72 |
| issn | 0273-2300 1096-0295 |
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| subjects | 560305 - Chemicals Metabolism & Toxicology- Vertebrates- (-1987) ANIMALS Biological and medical sciences CARCINOGENS CHRONIC EXPOSURE DATA DATA COMPILATION DOGS Drug Evaluation Drug Industry Drug-Related Side Effects and Adverse Reactions EUROPE EVALUATION General aspects. Methods Humans INFORMATION MAMMALS Medical sciences RADIATION, THERMAL, AND OTHER ENVIRON. POLLUTANT EFFECTS ON LIVING ORGS. AND BIOL. MAT RATS Research Design RODENTS SAFETY Species Specificity Time Factors TOXICITY Toxicology VERTEBRATES XENOBIOTICS |
| title | A critical appraisal of the duration of chronic animal toxicity studies |
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