Zdrowie i gospodarka · 21.08.1996
International Conference on Harmonisation; Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals
The Food and Drug Administration (FDA) is publishing a draft guideline entitled ``Testing for Carcinogenicity of Pharmaceuticals.'' This 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 outlines experimental approaches to evaluating the carcinogenic potential of pharmaceuticals to humans that may obviate the necessity for the routine conduct of two long-term rodent carcinogenicity studies.