ICH S4 Toxicity Testing Guidelines


S4 Toxicity Testing

S4 Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing)

The ICH Harmonised ICH Guideline was finalized under Step 4 in September 1998.

This guidance has been prepared for the development of medicinal products with the exception of those already covered by the ICH Guideline on Safety Studies for Biotechnological Products, e.g., Monoclonal antibodies, recombinant DNA proteins.

The text incorporates the guidance for repeat-dose toxicity tests that was agreed during the first ICH meeting in 1991 (reduction of the duration of repeat dose toxicity studies in the rat from 12 to 6 months).

Date of Step 4: 2 September 1998

Status: Step 5

Guidelines (Click the links below for complete guidelines)

*These Guidelines Belongs to ICH website.

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