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Related Experiment Video

Updated: May 17, 2026

Long-term Behavioral and Reproductive Consequences of Embryonic Exposure to Low-dose Toxicants

Long-term Behavioral and Reproductive Consequences of Embryonic Exposure to Low-dose Toxicants

Published on: March 6, 2018

Combined fertility and embryotoxicity study.

Lucie Reynaud¹, Edward Marsden

¹Ricerca Biosciences, Saint-Germain sur l'Arbresle, France. Lucie.reynaud@ricerca.com

Methods in Molecular Biology (Clifton, N.J.)

|November 10, 2012

Summary

This summary is machine-generated.

Combining fertility and embryo-fetal development studies, following ICH S5(R2) guidelines, reduces animal use and costs. This flexible approach streamlines reproductive toxicity testing for medicinal products.

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Determination of Reproductive Competence by Confirming Pubertal Onset and Performing a Fertility Assay in Mice and Rats

Published on: October 13, 2018

Area of Science:

Reproductive toxicology
Drug development
Preclinical safety assessment

Background:

Fertility and embryotoxicity studies are typically conducted separately per ICH S5(R2) guidelines.
The ICH S5(R2) guideline permits a flexible approach, allowing for combined study designs.

Purpose of the Study:

To evaluate the feasibility and benefits of combining fertility and embryo-fetal development studies.
To streamline the reproductive toxicity testing of medicinal products.

Main Methods:

A combined study design integrating fertility and embryo-fetal development stages (A to D) was considered.
Administration covers pre-mating and gestation phases up to hard palate closure.

Main Results:

The combined study design offers significant reductions in animal numbers.
Cost savings are a principal advantage of the integrated approach.

Conclusions:

Combining fertility and embryo-fetal development studies is a viable and efficient strategy.
This integrated approach aligns with the flexible nature of ICH S5(R2) guidelines for drug safety evaluation.