Regulated preclinical developmental and reproductive toxicity (DART) studies using mammalian research models are an important step to take before initiating clinical trials. Frontage’s scientists have over 20 years of experience running DART studies with knowledge of accurately estimating test doses, showing formulation stability, and expertise in animal handling. Our labs have the extensive capacity to run many studies, helping our sponsors meet their timelines with uncompromising quality.
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This webinar will provide a general overview of the regulatory guidelines required for developmental and reproductive toxicity (DART) testing. In order to initiate clinical trials for women of child-bearing potential (WOCBP), the FDA requires initiation of preclinical 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.
At Frontage, we provide comprehensive central lab services, including a range of laboratory testing, histology and pathology services, sample management, and global distribution. See our brochure about next-generation central lab services.
At Frontage, we offer extensive drug metabolism and pharmacokinetic capabilities for new chemical entities and compounds in development. We provide rapid turnaround of high-quality key DMPK data sets to support critical decisions in advancing potential therapeutic agents for further development. Our highly trained scientific staff applies state-of-the-art techniques and best-in-class approaches to provide broad and in-depth expertise/advice to clients on appropriate study designs, execution of studies, and interpretation of the data. DMPK studies can provide critical data during discovery and development of pharmaceutical and agrochemical products. Frontage’s DMPK services, performed in accredited facilities, can help support lead drug candidate or chemical selection, or help you meet specific regulatory requirements.