Zdrowie i gospodarka · 03/04/1997

International Conference on Harmonisation; Draft Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals; Availability

The Food and Drug Administration (FDA) is publishing a draft guideline entitled ``Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals.'' The draft guideline was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guideline identifies a standard set of genotoxicity tests to be conducted for pharmaceutical registration, and recommends the extent of confirmatory experimentation in in vitro genotoxicity tests in the standard battery. The draft guideline complements the ICH guideline ``Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals.''