International Conference on Harmonisation: guidance on testing for carcinogenicity of pharmaceuticals. Notice. Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is publishing a guidance entitled "S1B Testing for Carcinogenicity of Pharmaceuticals." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance 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
D000818:Animals; D015197:Carcinogenicity Tests / Q000592:standards*; D003226:Congresses as Topic; D017277:Drug Approval; D004353:Drug Evaluation, Preclinical / Q000592:standards*; D064420:Drug-Related Side Effects and Adverse Reactions; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D007391:International Cooperation; D007564:Japan; D051379:Mice; D051381:Rats; D014481:United States; D014486:United States Food and Drug Administration