Zdrowie i gospodarka · 01/03/1995

International Conference on Harmonisation; Guideline on Dose Selection for Carcinogenicity Studies of Pharmaceuticals; Availability

The Food and Drug Administration (FDA) is publishing a final guideline entitled ``Dose Selection for Carcinogenicity Studies of Pharmaceuticals.'' This guideline was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guideline examines criteria for establishing uniformity among international regulatory agencies for dose selection for carcinogenicity studies of human pharmaceuticals. The guideline is intended to help ensure that dose selection for carcinogenicity studies of pharmaceuticals to support drug registration is carried out according to sound scientific principles.