The participants with hemophilia received three injections of fitusiran administered either once weekly (at a dose of 0.015, 0.045, or 0.075 mg per kilogram) or once monthly (at a dose of 0.225, 0.45, 0.9, or 1.8 mg per kilogram or a fixed dose of 80 mg). That result has a positive impact on the business: fewer data errors means less risk at regulatory milestones and greater chance that drugs in development get to market faster and without data-related regulatory issues, said James Hayden, senior vice president, global sales and marketing.Ībout Certara Certara is dedicated to improving human health through a broad spectrum of software products and consulting services, from molecular discovery through clinical development, with special focus on supporting translational approaches to drug development.Įach Certara family brand focuses on a key phase within the drug discovery and development process combined, they offer a unique set of scientific modeling, analysis, and simulation capabilities that can enable the cross-disciplinary approaches necessary for translational science initiatives. This software solution benefits pharmaceutical and biotech RD and clinical trial staff by offering: Integrated connectivity between Phoenix workflows and external applications Seamless, error-free reporting, modeling and data management Enhanced compliance and speed to market Minimized regulatory risk ad costly exposure resulting from data errors Time savings associated with manual report generation (reducing effort from hours to minutes). Phoenix Winnonlin Generator The Integrated.
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