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All Times EDT

Friday, September 25
Fri, Sep 25, 3:30 PM - 4:45 PM
Virtual
Utility of Bayesian Approaches in Design and Analysis for Regulatory Approval of Medical Products

Applications of Bayesian Methods Within CDER (301240)

*Laura Fernandes, CDER FDA 

Keywords: Bayesian, pediatric, hierarchical models, subgroup analysis, master protocols

In this presentation I will present and discuss some recent examples of Bayesian methods seen within the Center for Drug Evaluation and Research (CDER). These will include use of Bayesian methods to incorporate adult data in pediatric clinical studies, applications of hierarchical models for subgroup analyses and use of Bayesian methods in master protocols.