Approaches to Address the Regulatory Requirements for System Qualification of the Simcyp Simulator

Physiologically-based pharmacokinetic (PBPK) modeling is being increasingly used in drug development to avoid unnecessary clinical drug-drug interaction (DDI) studies and inform drug labels. Thus, regulatory agencies are recommending more rigorous demonstration of the prediction accuracy of PBPK platforms in their intended use.
During this webinar, Certara experts present a framework for qualification of the Simcyp Simulator and discuss our strategy and ongoing qualification efforts for other key areas.
Certara accelerates medicines to patients using proprietary biosimulation software and technology to transform traditional drug discovery and development. Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries.
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