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.
Drug transporters can be major determinants of pharmacokinetics, drug-drug interactions, and the safety and efficacy of drugs. At Frontage, we have extensive experience in transporter research. We offer comprehensive transporter services to support projects from discovery to development, including screening and full characterization in both uptake and efflux transporter.
At Frontage, our scientific team has over a decade of experience in Microbiome to help you solve the development problems of therapeutics, probiotics and prebiotics.