This guidance is prepared to provide recommendations on nonclinical testing approaches to identify compounds which have the potential to be immunotoxic, and guidance on a weight-of-evidence decision making approach for immunotoxicity testing.
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ICH S8 Guideline 2006. Note For Guidance on Immunotoxicity Studies for Human Pharmaceuticals (Chmp/167235/2004).
Published by European Medicines Agency (EMA)International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
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