ICH S1C (R2) Dose selection for carcinogenicity studies of pharmaceuticals

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Current effective version

Adopted guideline

Reference numberCPMP/ICH/383/95
Effective from01/10/2008
KeywordsCarcinogenity studies, dose selection, maximum tolerated dose (MTD), AUC ratio, saturation of absorption, maximum feasible dose, limit dose
DescriptionThis document outlines criteria for selection of the high dose for carcinogenicity studies of therapeutics. It proposes approaches that could be useful for dose selection.

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