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Activity Details


353 Tue, 8/6/2013, 10:30 AM - 12:20 PM CC-512e
Modeling Clinical Trial Data: PK and Other Applications — Contributed Papers
Biopharmaceutical Section , Biometrics Section
Chair(s): John Han, Janssen Research and Development
10:35 AM Unified Assessment of QTc and PK Concentration Data in a Thorough QTc Study Using an Index Set, Indexed by Monotonic Order of PK Concentrations Anura Abeyratne, Astellas Pharma Global Development, Inc
10:50 AM Assessment on Efficiency of Drug Delivery via ET(p) Under Nonlinear Mixed Effects Models Qianqiu Li, Janssen Research & Development ; Kedar Gokhale, Janssen Research & Development ; Chao Wang, Janssen Research & Development ; Dhammika Amaratunga, Janssen Research & Development
11:05 AM On Optimal Model-Based Design of Pharmacokinetic/Pharmacodynamic Studies Sergei Leonov, AstraZeneca
11:20 AM Model-Based Power Calculations for Clinical Pharmacology Studies with Illustration Using SAS Proc Power Peng Sun, GlaxoSmith Kline
11:35 AM Generalized Response Surface Models for Assessing Synergistic Effects of Three or More Drugs John Oleynick, Janssen Research & Development ; Yong Lin, University of Medicine and Dentistry of New Jersey ; Dirk Moore, University of Medicine and Dentistry of New Jersey ; Weichung Joe Shih, University of Medicine and Dentistry of New Jersey
11:50 AM Generalized Optimal Design for Two-Arm, Randomized Phase II Clinical Trials with Endpoints from the Exponential Dispersion Family Wei Jiang, University of Kansas Medical Center ; Jonathan Mahnken, The University of Kansas Medical Center ; Jianghua He, University of Kansas Medical Center ; Matthew S. Mayo, University of Kansas Medical Center
12:05 PM Adjusting for Partially Missing Baseline Measurements with Nonlinear Models in Randomized Trials Chunyao Feng, Amgen Inc. ; Chunlei Ke, Amgen



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