ICH S8 Immunotoxicity studies for human pharmaceuticals

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Current effective version

Adopted guideline

Reference numberCHMP/ICH/167235/04
Published31/10/2005
Effective from01/05/2006
KeywordsImmunotoxicity, immune system, immunosuppression, immunoenhancement, study design
DescriptionThis 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.


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