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

  • Email
  • Help
Current version

Revision 2 - Adopted guideline

Currently under revision - see below

Reference numberCPMP/ICH/386/95
Published30/09/1993
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

Published: 31/09/2017

 

Deadline for comments: 28/02/2018

 

Revision 2

Current version

Adopted guideline

Published: 30/09/1993

 

In operation: 01/03/1994-present

 


Related content


How helpful is this page?

Average rating:

 Based on 0 ratings

Add your rating:

See all ratings
0 ratings
0 ratings
0 ratings
0 ratings
0 ratings
    

Tell us more