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.
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In this white paper, we show testing of two critical parameters for the method validation of Gyrolab: 1) carryover contamination and 2) after MRD (minimum required dilution) stability.
In this webinar, speaker Christopher Gilmer introduces microbiological testing for raw materials, APIs, and finished products, discusses the validation of methods and product testing requirements, and clarifies general procedures to investigate unexpected results.
In this white paper, we provide an overview of how CROs can support the analysis of biologics with an emphasis on in-depth structural elucidation, product release requirements, and stability testing (including degradation pathway studies).