Developmental and Reproductive Toxicology (DART) Services
In order to initiate clinical trials for women of child-bearing potential (WOCBP), the FDA requires 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.
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 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, 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.
- 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.
Frontage Expands Toxicology Services Through the Acquisition of Experimur
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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.Learn More