Learn How Discovery Data Technology Enables Faster Discovery Research

Thu, Nov 4, 2021 1:00 PM – 2:00 PM EDT Drug discovery research requires understanding complex chemical, biological, logistical, and computational data from a wide variety of data sources. A key challenge for discovery scientists is efficiently accessing the most relevant data from internal and external data sources in a cohesive project data view. Manual … Continued

Simcyp for Accelerating Polymer Drug Development

November 30th, 4-5pm JST How does Simcyp Biologics work? By Felix Stader, Sr. Research Scientist, Res&Dev, Certara In the session, we will look at the capabilities of the Simcyp Simulator to predict the pharmacokinetics of therapeutic proteins. The structure and the fundamental underlying assumptions of the model will be covered as well as different clearance … Continued

Overview of the Phoenix platform – Applications for CAR-T cell modeling

Thu, Oct 28th, 9:00 am – 10:30 am CST (China Standard Time) Phoenix software is the gold standard for pharmacokinetic/pharmacodynamic (PK/PD) and toxicokinetic modeling and simulation. The platform is increasingly recognized as the key software for reviewing new drugs and biologics marketing applications. In this webinar, Certara and guest speakers will introduce you to the … Continued

eCTD electronic filing to fulfill regulatory requirements

Thu, December 9th, 9:00 am – 10:30 am CST (China Standard Time) GlobalSubmit™ software supports clinical studies and trials, marketing applications, and compliance with 21 CFR Part 11 specifications. It also integrates seamlessly with the industry’s leading electronic document management system (eDMS).Streamlining the eCTD submission process will increase your efficiency, reduce risk, and ensure no … Continued

Model-based DDI Extrapolation Strategy from Adults to Children – A Case Study with Risdiplam

Risdiplam (EVRYSDI) is approved for the treatment of patients with spinal muscular atrophy ≥ 2 months old. CYP3A-mediated DDI risk in pediatric patients was evaluated by physiologically-based pharmacokinetic (PBPK) modelling and informed the label. This talk will illustrate a modeling strategy for the extrapolation of DDIs from adults to children covering: Development of a patient-specific … Continued

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