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