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