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

Table of contents

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


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