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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"...

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