JSM 2011 Online Program

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240 *	Mon, 8/1/2011, 2:00 PM - 3:50 PM	CC-C219
Issues with Analysis of QT/QC and Safety — Contributed Papers
Biopharmaceutical Section
Chair(s): Wei Zhang, U.S. Food and Drug Administration
2:05 PM	Nonparametric Approaches to Assess the Risk of QT Prolongation of an Investigational New Drug — Kristin Ashley Linn, North Carolina State University ; Sujit Kumar Ghosh, North Carolina State University
2:20 PM	Estimating the Hazard Rate Accounting for Bias in Safety Reporting in a Long-Term Safety Follow-Up Study — Prasheen K. Agarwal, Johnson & Johnson Pharmaceutical R&D, LLC ; Jiandong Lu, Johnson & Johnson Pharmaceutical R&D, LLC
2:35 PM	Handling Hierarchical Data Structure in the Safety Evaluation — Huanyu Chen, U.S. Food and Drug Administration
2:50 PM	On the Relationship Between Baseline Correction Method and Covariance Structure for Analysis of a Thorough QT Crossover Study — Wenqing Li, Novartis Oncology Biometrics and Data Management ; Andrea Lynn Maes, Novartis Oncology Biometrics and Data Management ; Michelle Quinlan, Novartis Oncology Biometrics and Data Management ; Suraj Anand, Novartis Oncology Biometrics and Data Management
3:05 PM	Floor Discussion

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