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407 * Thu, 8/12/2021, 2:00 PM - 3:50 PM Virtual
Toward a Regulatory Guidance for the Use of Bayesian Methods in Nonclinical CMC Statistics — Topic-Contributed Papers
Section on Bayesian Statistical Science, Biopharmaceutical Section, Quality and Productivity Section
Organizer(s): Paul Faya, Eli Lilly and Compnay
Chair(s): Paul Faya, Eli Lilly and Compnay
2:05 PM Toward a Regulatory Guidance for Bayesian Statistics in CMC Studies
Dave LeBlond, Consultant
2:25 PM Gaussian Process Modeling for Dissolution Curve Comparisons
Tony Pourmohamad, Genentech, Inc.; Cristian Oliva Aviles, Genentech, Inc.; Robert Richardson, Brigham Young University
2:45 PM Informative Priors for Formal Stability Studies
Percy Sondag, Merck Center for Mathematical Sciences
3:05 PM Floor Discussion