ICH S5 (R2) reproductive toxicology: detection of toxicity to reproduction for human pharmaceuticals

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Current version

Revision 2 - Adopted guideline

Currently under revision - see below

Reference numberCPMP/ICH/386/95
Effective from01/03/1994
KeywordsReproductive toxicity, selection of species, study design, fertility, embryo-fetal development, prenatal development, postnatal development
DescriptionThis document gives recommendations on the strategy of reproductive toxicity testing of chemicals and medicinal products. It also addresses the male fertility investigation.

Document history

Revision 3

In progress

Draft guideline


Overview of comments

Published: 31/09/2017


Published: 26/04/2018


Revision 2

Current version

Adopted guideline

Published: 30/09/1993


In operation: 01/03/1994-present


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