S5(R2): Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility

Regulatory Resource: S5(R2): Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility

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S5(R2): Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility

The core tripartite harmonised ICH guideline was finalised (Step 4) in June 1993. This document provides guidance on tests for reproductive toxicity. It defines the periods of treatment to be used in animals to better reflect human exposure to medical products and allow more specific identification of stages at risk.

The addendum to the core ICH guideline above with respect to male fertility studies was finalised (Step 4) in November 1995. The guideline has been amended on November 9, 2000, under the Maintenance Process.

The amendments provide a better description of the testing concept and recommendations, especially those addressing flexibility, pre-mating treatment duration, and observations.

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