Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use (ICH Topic S2 (R1)

Title:
Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use (ICH Topic S2 (R1)
Short Title:
EMEA/CHMP/ICH/126642/2008

https://www.gmp-compliance.org/files/guidemgr/EMEA_Genotoxicity_Testing_2008.pdf

Origin/Publisher:

Content:
This guidance replaces and combines the ICH S2A ahnd S2B guidelines and focuses on the the testing of "Small molecule" drug substances.

Go back