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579 * ! Wed, 8/2/2017, 2:00 PM - 3:50 PM CC-320
Tests of Noninferiority in the Clinical Trial Setting — Contributed Papers
Biopharmaceutical Section
Chair(s): Adam Hamm, Cytel, Inc.
2:05 PM Bayesian Approach of Assessing Non-Inferiority of a New Treatment with Binary Outcomes in a Three-Arm Trial Shrabanti Chowdhury ; Samiran Ghosh, Wayne State University - Detroit, MI ; Ram Tiwari, FDA/CDER/OT/OB
2:20 PM A Simple Mantel-Haenszel Type Test for Non-Inferiority Kallappa Koti
2:35 PM Ratio of Means vs. Difference of Means Non-Inferiority or Equivalence Tests -Difference in Adjustment for Covariates Wanjie Sun, FDA ; Stella Grosser, FDA
2:50 PM Non-Inferiority Trial Design by Considering Maximally/Minimally Observed Treatment Difference Shufang Liu, Astellas Pharma ; Misun Lee, Astellas Pharma
3:05 PM Use of Historical Control Data in the Analysis of a Non-Inferiority Trial Isaac Nuamah, Janssen R & D ; Youping Huang, Janssen R&D ; Yevgen Tymofyeyev, Janssen R&D
3:20 PM Statistical Methods for Equivalence Assessment of Analytical Biosimilar Yi Tsong, CDER, FDA ; Meiyu Shen, C DER, FDA ; Yu-Ting Weng, FDA ; Chao Wang, CDER/FDA ; Li Xing, CDER/FDA
3:35 PM Immunogenicity Study Design for Biosimilar Approval Junshan Qiu, FDA ; Mike Mikailov, FDA ; Ram Tiwari, FDA/CDER/OT/OB
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