ICH S8 Immunotoxicity studies for human pharmaceuticals - Scientific guideline

This document provides recommendations on non-clinical testing for immunotoxicity induced by human pharmaceuticals. It is restricted to unintended immunosuppression and immunoenhancement, excluding allergenicity or drug-specific autoimmunity.

Keywords: Immunotoxicity, immune system, immunosuppression, immunoenhancement, study design

Current effective version

ICH: S 8: Immunotoxicity studies for human pharmaceuticals - Step 5

Adopted Reference Number: CHMP/167235/2004 Legal effective date: 01/05/2006