ICH S8 Immunotoxicology Studies Guidelines


S8 Immunotoxicology Studies

S8 Immunotoxicity Studies for Human Pharmaceuticals

The ICH Harmonised Guideline was adopted under Step 4 in September 2005. This Guideline provides 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 It applies to new pharmaceuticals intended for use in humans, as well as to marketed pharmaceuticals proposed for different indications or other variations on the current product label in which the change could result in unaddressed and relevant immunotoxicity issues.

In addition, the Guideline might also apply to drugs in which clinical signs of immunotoxicity are observed during clinical trials and following approval to market.

Date of Step 4: 15 September 2005

Status: Step 5

Guidelines (Click the links below for complete guidelines)

S8 Guidelines

Endorsed Document (Click the links below for complete guidelines)

S8 Concept Paper

*These Guidelines Belongs to ICH website.

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