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541 * Thu, 8/6/2020, 1:00 PM - 2:50 PM Virtual
Informative Prior Applications in Nonclinical CMC Statistics — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Paul Faya, Eli Lilly and Company
Chair(s): John J. Peterson, GSK
1:05 PM Informative Priors for Justification of Specifications (JoS)
Dwaine Banton
1:25 PM Bayesian Concepts in Process Validation: Designing a Process Performance Qualification (PPQ)
Timothy Mutsvari, Pharmalex
1:45 PM Platform Priors for Early-Phase CMC Development Studies
Paul Faya, Eli Lilly and Company
2:05 PM A Bayesian Statistical Approach to Continuous Qualification of a Bioassay
Steven Novick, AstraZeneca
2:25 PM Discussant: Meiyu Shen, FDA
2:45 PM Floor Discussion