ICH S8 Immunotoxicity studies for human pharmaceuticals - Scientific guideline

Table of contents

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


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