In Brief: ICH carcinogenicity guideline
Executive Summary
ICH carcinogenicity guideline: International Conference on Harmonization draft guideline on "testing for carcinogenicity of pharmaceuticals" is published in the Aug. 21 Federal Register and designates a 60-day written comment period. The draft outlines experimental approaches for evaluating the carcinogenic potential of pharmaceuticals to humans "that may obviate the necessity for the routine conduct of two long-term rodent carcinogenicity studies"...