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

HumanScientific guidelines

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This document outlines criteria for selection of the high dose for carcinogenicity studies of therapeutics. It proposes approaches that could be useful for dose selection.

Keywords: Carcinogenity studies, dose selection, maximum tolerated dose (MTD), AUC ratio, saturation of absorption, maximum feasible dose, limit dose

Current effective version

ICH: S 1 C (R2): Dose selection for carcinogenicity studies of pharmaceuticals - Step 5

Adopted Reference Number: EMEA/CHMP/ICH/383/1995 Legal effective date:

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