Regulated DART studies by highly experienced scientists.

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

Need a refresher? Here’s a complete overview of what DART studies are and why they are essential.

Or talk to our in-house DART experts!

Study Types 

Frontage has a highly trained technical staff and expert scientists with a long history of successfully performing specialized toxicology studies, including regulated developmental and reproductive toxicity studies. Specifically, we have the capabilities to do these 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, the process of parturition, and the development of the offspring. 
• Single and multi-generation studies are also available. 
• The typical species for DART studies include rats and rabbits via multiple routes of administration. 

Webinar: Guidelines for Developmental and Reproductive Toxicity (DART) Testing

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 and large molecules, and biomarkers. 

GLP-Compliant Toxicology Services

Our facility in Chicago, Illinois, provides full service, GLP-compliant toxicology and related non-clinical development services supporting the pharmaceutical and biotechnology industries.

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Genetic Toxicology

Frontage offers the portfolio of assays and designs to meet all regulatory requirements for IND in Genetic Toxicology testing.

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Specialized Toxicology

Frontage provides comprehensive coverage by offering a wide selection of test species and multiple drug administration routes, to help prepare your compounds for IND and NDA submissions.

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Developmental and Reproductive Toxicology (DART) Services

Regulated DART studies by highly experienced scientists

Specialized Toxicology Services

Qualifying your drugs for NDA submissions