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 Center 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.
- Research Organization:
- Centre for Medicines Research, Carshalton, England
- OSTI ID:
- 5573551
- Journal Information:
- Regul. Toxicol. Pharmacol.; (United States), Vol. 1
- Country of Publication:
- United States
- Language:
- English
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CARCINOGENS
EVALUATION
XENOBIOTICS
TOXICITY
CHRONIC EXPOSURE
DATA COMPILATION
DOGS
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DATA
INFORMATION
MAMMALS
RODENTS
VERTEBRATES
560305* - Chemicals Metabolism & Toxicology- Vertebrates- (-1987)