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.