Guidelines for Developmental and Reproductive Toxicity (DART) Testing

This webinar will provide a general overview of the regulatory guidelines required for developmental and reproductive toxicity (DART) testing. In order to initiate clinical trials for women of child-bearing potential (WOCBP), the FDA requires initiation of preclinical DART studies using mammalian research models. These regulated studies provide important information regarding the effects of drug exposures prior to and during parental mating, as well as evaluating maternal and fetal changes during gestation, and identifying any alterations in the development of the offspring following birth.

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