International Conference on Harmonisation; Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals; availability. Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "S8 Immunotoxicity Studies for Human Pharmaceuticals." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides recommendations on nonclinical testing approaches to identify compounds that have the potential to be immunotoxic and guidance on a weight-of-evidence decision making approach for immunotoxicity testing. The guidance is intended to provide recommendations on nonclinical testing for immunotoxicity induced by human pharmaceuticals. The guidance applies to unintended immunosuppression and immunoenhancement, excluding allergenicity or drug-specific autoimmunity.
D002626:Chemistry, Pharmaceutical / Q000592:standards; D003226:Congresses as Topic; D003601:Cytotoxicity Tests, Immunologic / Q000592:standards*; D064420:Drug-Related Side Effects and Adverse Reactions; D005060:Europe; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D007154:Immune System Diseases / Q000139:chemically induced; D000922:Immunotoxins / Q000009:adverse effects; D066298:In Vitro Techniques; D007391:International Cooperation; D007564:Japan; D018675:Toxicity Tests / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration
D000922:Immunotoxins