[Significance of mutagenicity tests on safety evaluation of medicinal drugs].
As one of toxicological tests for safety evaluation of medicinal drugs, three representative mutagenicity tests, that is, reverse mutation test in bacteria, chromosomal aberration test with mammalian cells in culture and micronucleus test with rodents have been carried out. These three tests, especially two in vitro tests have been used for initial hazard identification. Further, the micronucleus test using experimental animals has offered significant information for in vivo safety evaluation. Based on recent collaborative studies with mouse micronucleus tests on human carcinogens and results from newly developed in vivo gene mutation assay using transgenic mice, the combination of both test systems seems to be powerful for in vivo safety evaluation.
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D000818:Animals; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D051379:Mice; D008822:Mice, Transgenic; D009152:Mutagenicity Tests