Developmental and Reproductive Toxicity (DART) Services

In order to initiate clinical trials for women of child-bearing potential (WOCBP), the FDA requires initiation of preclinical developmental and reproductive toxicity (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. 

Study Types 

Frontage has a highly trained technical staff and expert scientists with a long history of successfully performing regulated DART studies. Specifically, we have capabilities to do the following studies following the ICH S5 (R3) Guideline: 

• Fertility and Early Embryonic Development (FEED) study: Evaluates the effects on mating, estrous cyclicity, spermatogenesis, and ability to produce a viable implant. Sperm count, motility, and morphology are assessed with a Hamilton-Thorne Analyzer. 

• Embryofetal Development (EFD) study: Demonstrates the effects of gestational exposure on the pregnant female and the developing fetus during the organogenesis period. 

• Pre- and Post-natal (PPND) study: Quantifies the effect of gestational and lactational maternal exposure on embryonic development, process of parturition, and development of the offspring. 

• Single and multi-generation studies are also available. 

• The typical species for DART studies include the rat and rabbits via multiple routes of administration. 

Advantages

• Frontage’s Safety and Toxicology team has highly qualified scientists with focused expertise in DART and specialized toxicology services. 
• At Frontage, we have extensive DART historical control data available. 
• Frontage has exceptional bioanalytical supporting capabilities for small molecules, large molecules, and biomarkers.