Preclinical evaluation of radiopharmaceutical toxicological prerequisites.
Radiopharmaceuticals should be tested in a battery of assays to evaluate human risk assessment, as for every drug. The battery of tests used for this evaluation should be adapted taking into account the specificity of radiopharmaceuticals and particularly the short duration of treatment, the toxicity associated both to the unlabelled part of the molecule and to the radioactivity itself, but also to a specific type of impurities due to the radiolytic degradation products.
Marzin
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Institut Pasteur De Lille-Laboratoire De Toxicologie-1, France. Daniel.Marzin@pasteur-lille.fr
D000818:Animals; D015197:Carcinogenicity Tests; D002986:Clinical Trials as Topic; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D008297:Male; D009152:Mutagenicity Tests; D019275:Radiopharmaceuticals / Q000009:adverse effects / Q000627:therapeutic use / Q000633:toxicity*; D012098:Reproduction / Q000187:drug effects; D018675:Toxicity Tests
D019275:Radiopharmaceuticals