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Sessions Were Renumbered as of May 19.

CC-W = McCormick Place Convention Center, West Building,   CC-N = McCormick Place Convention Center, North Building
H = Hilton Chicago,   UC= Conference Chicago at University Center
* = applied session       ! = JSM meeting theme

Activity Details

546 * ! Wed, 8/3/2016, 10:30 AM - 12:20 PM CC-W184d
Noninferiority Studies — Contributed Papers
Biopharmaceutical Section , International Chinese Statistical Association
Chair(s): Pilar Lim, Janssen R&D
10:35 AM Clinical Trial Design of Authorized Biosimilars in Europe Johanna Mielke, Novartis Pharma AG ; Bernd Jilma, Medical University of Vienna ; Byron Jones, Novartis Pharma ; Franz Koenig, Medical University of Vienna
10:50 AM Average Inferiority Measure and Standardized Margins to Address Issues in Biosimilar Trials Gang Li, Johnson & Johnson ; Weichung J. Shih, Rutgers University
11:05 AM Various Approaches to Calculate 95% CIs of Treatment Difference from a Stratified Noninferiority Trial Qiaoyang Lu, Astellas Pharma ; Misun Lee, Astellas Pharma
11:20 AM Bayesian Design of Phase II Noninferiority (NI) Safety Clinical Trial Lu-May Chiang, Novartis Pharma ; David Ohlssen, Novartis ; Dong Xi, Novartis
11:35 AM The Role of Multiple Imputation in Noninferiority Trials Brian Wiens, Portola Pharmaceuticals ; Ilya Lipkovich, Quintiles
11:50 AM Is It Valid to Claim Superiority in a Noninferiority Trial? Jitendra Ganju, Global Blood Therapeutics
12:05 PM Noninferiority Tests for Anti-Infective Drugs Using Control Quantiles Michael Fay, National Institute of Allergy and Infectious Diseases ; Dean Follmann, National Institute of Allergy and Infectious Diseases
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