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.