Developmental And Reproductive Toxicology (DART) Studies: What Are They, And How Do They Fit Into Your Program?

By Camille Delouche, MSc, Camargo Accelerator Program Associate

Development and Reproductive Toxicology studies, or DART studies, are required for most non-oncology programs between IND and NDA filings. Their goal is to detect any effects of a drug within a complete reproductive cycle as relevant to humans: from initial conception to reproductive capacity in the next generation. They can be designed to measure the effects of a drug on male and female fertility, the full span of embryonic and fetal development (EFD), and pre- and post-natal development (PPND) including gestation, parturition, lactation, and teratology. In addition, juvenile studies performed on an as-needed basis can look at a drug’s impact on neonates to adolescents.