Teratogenicity

Teratogenicity refers to the ability of a substance to cause abnormalities in the development of an embryo or fetus, leading to birth defects. In the context of drugs regulatory affairs, teratogenicity is a critical aspect that regulatory agencies such as the FDA (Food and Drug Administration) in the United States or the EMA (European Medicines Agency) in Europe closely assess during the drug approval process.

Here's a breakdown of how teratogenicity is addressed in drugs regulatory affairs:

1. Preclinical Studies: Before a drug can be tested in humans, it undergoes extensive preclinical studies, which include animal studies. These studies aim to ___ _________ _______ _________ _________ _______ _______ ____.
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