The ICH S8 immunotoxicity guidance. Immune function assessment and toxicological pathology: Autonomous or synergistic methods to predict immunotoxicity?

In conclusion, to detect and evaluate potential immunotoxic effects of human pharmaceuticals the ICH S8 guideline allows for a more flexible, scientifically sound approach. For a proper evaluation of potential immunotoxic effects integration of data from standard toxicological parameters like clinical pathology, histopathology and functional assays are important.