Issue Date: November 21, 1997
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Safety
Status: Final
S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals
Two fundamental areas in which harmonization of genotoxicity testing for pharmaceuticals is considered necessary are the scope of this guidance: (1) Identification of a standard set of tests to be conducted for registration. (2) The extent of confirmatory experimentation in in vitro genotoxicity tests in the standard battery. Further issues that were considered necessary for harmonization can be found in the ICH guidance S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals. The two ICH guidances on genotoxicity complement each other and therefore should be used together as ICH guidance principles for testing of a pharmaceutical for potential genotoxicity.
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