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Activity Details


305 * Tue, 8/5/2014, 8:30 AM - 10:20 AM CC-156C
Statistical Issues in Drug Development and Labeling — Contributed Papers
Biopharmaceutical Section
Chair(s): Alvin VanOrden, FDA   
8:35 AM Bias and Incorrect Confidence Interval Coverage in Prescription Drug Labeling Gregory Levin
8:50 AM Improving Early Decisionmaking for Alzheimer's Disease Robin Mogg, Merck ; Devan V. Mehrotra, Merck ; Arthur Simen, Merck
9:05 AM Assessing Placebo Response in Chronic Pain Trials by Latent Subgroup Analysis Models Xiaopeng Miao, Biogen Idec ; Yan Zhou, University of Michigan ; Narinder Nangia, AbbVie
9:20 AM Design and Modeling Considerations for Skin Permeation Studies Areti Manola, Janssen ; Juan Chen, Janssen ; Jyh-Ming Shoung, Janssen ; Stan Altan, Janssen
9:35 AM A Comparative Analysis of Holter Recordings from a Thorough QT (TQT) Study Using Highly Automated Systems vs. a Standard Semi-Automated Method Li Fan, Merck ; Patrick J. Larson, Merck ; Anis Khan, Merck ; David Gutstein, Merck ; Matt S. Anderson, Merck
9:50 AM Floor Discussion



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