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245 * Mon, 7/30/2012, 2:00 PM - 3:50 PM CC-Room 23B
Planning and Analysis of Noninferiority Studies — Contributed Papers
Biopharmaceutical Section
Chair(s): Mary Almas, Pfizer Inc.
2:05 PM Sample Size Consideration in Noninferiority Designs Chengxing Lu, Novartis ; Xing Sun, Merck
2:20 PM The Stochastic Curtailment of Long-Term Clinical Trials for Noninferiority Case vs. Superiority Case and Its Visualization Shaoyi Li, Celgene Corporation
2:35 PM Estimating the Effect Size of Approved Drugs for the Treatment of Bacterial Conjunctivitis Studies Yan Wang, FDA/CDER/OTS/OB ; Yunfan Deng, FDA/CDER/OTS/OB ; Daphne Lin, FDA ; Jennifer Harris, FDA/CDER/OND/OAP/DTOP
2:50 PM A Simple Approach in Determining Sample Size and Power for Assessing Noninferiority of a Test Treatment When There Is a Placebo Jerry Weaver, Novartis
3:05 PM Inferiority Index and the Behrens-Fisher Problem for Noninferiority Trials George Y.H. Chi, Janssen Pharmaceuticals R&D
3:20 PM Comparisons of Noninferiority Methods When the Control Group Rate Is Low (= 10%) Alison Pedley, Merck ; Joseph Massaro, Boston University ; Robert W. Tipping, Merck
3:35 PM The Issue of Multiplicity in Noninferiority Studies Chunlei Ke, Amgen, Inc. ; Beiying Ding, Amgen, Inc. ; Qi Jiang, Amgen, Inc. ; Steven Michael Snapinn, Amgen, Inc.



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