ABSTRACT
Publication of ICH S8 guidance ‘Immunotoxicity Studies For Human Pharmaceuticals’ (ICH S8, 2005) resulted from an international consensus that evaluation of potential adverse effects of human pharmaceuticals on the immune system should be incorporated into standard drug development. According to ICH S8, toxicity to the immune system includes unintended immunosuppression or enhancement of the immune response. Suppression of immunity can result in decreased host resistance to infectious agents or tumours, whereas induction or enhancement of the immune response can induce autoimmune diseases or hypersensitivity. ICH S8 does not apply to biotechnology-derived products [covered
by ICH S6 Guideline (ICH S6, 1998)] because their special properties will have been explored during other investigations.
