Issue Date: April 12, 2006
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Safety
Status: Final
S8 Immunotoxicity Studies for Human Pharmaceuticals
The objectives of this guidance are to provide (1) recommendations on nonclinical testing approaches to identify compounds that have the potential to be immunotoxic and (2) guidance on a weight-of-evidence decisionmaking approach for immunotoxicity testing. Immunotoxicity is, for the purpose of this guidance, defined as unintended immunosuppression or enhancement. Drug-induced hypersensitivity and autoimmunity are excluded.
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