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

AdoptedLegal effective date: Reference Number: CHMP/167235/2004

English (EN) (132.74 KB - PDF)

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