ICH S1A Need for carcinogenicity studies of pharmaceuticals - Scientific guideline

This document defines the conditions under which carcinogenicity studies should be conducted to avoid the unnecessary use of animals in testing.

Keywords: Carcinogenicity studies, tumorigenic potential, duration of treatment, genotoxicity

Current effective version

ICH: S 1 A: The need for carcinogenicity studies of pharmaceuticals - Step 5

Adopted Reference Number: CPMP/ICH/140/95 Legal effective date: 01/07/1996