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  • Title: [Preclinical research--toxicology].
    Author: Frohberg H.
    Journal: Arzneimittelforschung; 1975 Jul; 25(7a):1101-10. PubMed ID: 1242337.
    Abstract:
    The different steps of the toxicological testing of new drugs are shortly described. Furthermore it is discussed that only 60-70% of the drug induced adverse reactions in man can be predicted by the experimental methods being available at present. Special problems exist in evaluating the results of reproductive-toxicological, carcinogenicity and mutagenicity tests. These problems are illustrated by some experimental and clinical examples. Toxicological testing of new drugs is briefly described. Only 60-70 % of the adverse drug reactions in human beings can be predicted by presently available experimental methods. Special problems exist in the evaluation of reproductive-toxicity, carcinogenicity, and mutagenicity tests. The example of the carcinogenic effect of chlormadinone acetate, when given to beagles at doses 2-25x greater than the human therapeutic dose, is cited, in addition to several examples of antineoplastic agents .
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