Sessions Were Renumbered as of May 19.
Legend:
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
