JSM 2011 Online Program

The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.

Activity Details


351 *	Tue, 8/2/2011, 10:30 AM - 12:20 PM	CC-C220
Issues in Early Development and Pharmacokentic Studies — Contributed Papers
Biopharmaceutical Section
Chair(s): Terri Kang Johnson, U.S. Food and Drug Administration/CDRH
10:35 AM	When Is a Biomarker-Based Study Design in Drug Development Likely to Succeed? — Deepak B. Khatry, MedImmune, Inc.
10:50 AM	Can Traditional Pharmacokinetic Nonlinear Models Be Replaced with Random Effects Linear Models? — Francisco J. Diaz, University of Kansas Medical Center
11:05 AM	A Range of Practical Issues in Pediatric Early Phase Trials: Dosing Approaches and Empirical vs. Model-Based Phase I Designs — Arzu Onar-Thomas, St. Jude Children's Research Hospital
11:20 AM	Statistical Methods and General Principles of Exposure-Response Analysis — Rui Tang, Amgen Inc. ; Erik Rasmussen, Amgen Inc. ; Hongjie Deng, Amgen Inc. ; Lisa Hendricks, Amgen Inc. ; Mike Hale, Amgen Inc. ; Li Chen, Amgen Inc.
11:35 AM	A New Statistical Method for Estimating a Clinically Meaningful Threshold — Xin Fang, U.S. Food and Drug Administration ; Mahboob Sobhan, U.S. Food and Drug Administration
11:50 AM	Statistical Inference for Dynamic Systems Governed by Differential Equations with Applications to Toxicology — Siddhartha Mandal, The University of North Carolina at Chapel Hill ; Pranab K. Sen, The University of North Carolina at Chapel Hill ; Shyamal D. Peddada, National Institute of Environmental Health Sciences
12:05 PM	The Real Implication of Incorporating PK Into Dose-Escalation Trials — Cheng Zheng, Novartis ; Lu-May Chiang, Novartis ; Pai-Hsi Huang, Novartis

2011 JSM Online Program Home

For information, contact jsm@amstat.org or phone (888) 231-3473.

If you have questions about the Continuing Education program, please contact the Education Department.