In order to understand the potential of a drug to induce birth defects in offspring, teratogenic studies must be performed. Reproductive toxicity is a major concern and different guidelines, such as the ICH S5(R2) guideline, state the need to assess chemicals safety during the Drug Discovery and Development Process or before drug commercialization.
The zebrafish embryo is an emerging model due to its inherent properties (ease of manipulation, external fertilization and transparency) together with the need to apply the 3Rs. This model has a high genetic homology with humans (over 85%) as well as important parallels in organogenesis and functional mechanisms.