ICH S2 (R1) Genotoxicity testing and data interpretation for pharmaceuticals intended for human use - Scientific guideline
Table of contents
This document aims to optimize the standard genetic toxicology battery for prediction of potential human risks. It describes internationally agreed upon standards for follow-up testing and interpretation of positive results in vitro and in vivo in the standard genetic toxicology battery, including assessment of non relevant findings. This guidance does not apply to biologics.
Keywords: Genotoxicity, standard test battery, in vitro test, in vivo test, results interpretation
-
List item
S 2 A: Note for guidance on genotoxicity: Specific aspects of regulatory genotoxicity tests for pharmaceuticals (PDF/167.12 KB)
Adopted
First published: 01/04/1996
Last updated: 01/04/1996
Legal effective date: 01/04/1996
CPMP/ICH/141/95 -
List item
S 2 B: Note for guidance on genotoxicity: A standard battery for genotoxicity testing of pharmaceuticals (PDF/165.78 KB)
Adopted
First published: 01/03/1998
Last updated: 01/03/1998
Legal effective date: 01/03/1998
CPMP/ICH/174/95