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S8 - PharmaFacts
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Guidances - ICH Guidances

S8: Immunotoxicology Studies for Human Pharmaceuticals:

The Guideline reached Step 4 of the ICH process on 15 September 2005. This guideline addresses the recommendations on nonclinical testing for immunosuppression induced by low molecular weight drugs (non-biologicals). It applies to new pharmaceuticals intended for use in humans, as well as to marketed drug products proposed for different indications or other variations on the current product label in which the change could result in unaddressed and relevant toxicologic issues. In addition, the guideline might also apply to drugs in which clinical signs of immunosuppression are observed during clinical trials and following approval to market. The term immunotoxicity in this guideline will primarily refer to immunosuppression, i.e. a state of increased susceptibility to infections or the development of tumors. It is beyond the scope of this guideline to provide specific guidance on how each immunotoxicity study should be performed. General guidance is provided in Appendix 1.