Abstract Details
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Activity Number:
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17
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Type:
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Topic Contributed
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Date/Time:
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Sunday, August 4, 2013 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #309669 |
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Title:
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Role of Exploratory Biomarker and Exposure-Response Analyses in Evidence-Based Designs
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Author(s):
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Li Chen*+ and Hongjie Deng and Erik Rasmussen and Rui Tang and Mike Hale
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Companies:
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Amgen Inc. and Amgen Inc. and Amgen Inc. and Amgen and Amgen
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Keywords:
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dose-selection ;
model-base design
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Abstract:
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Personalized medicine is a rapidly advancing field aiming to optimize health care using our molecular understanding of disease characterized by biomarkers (such as clinical, genetic and genomic markers). Model-based drug development is a new paradigm recognized as an initiative able to improve success rates in the development of new agents. Exposure-response modeling and exploratory biomarker analyses play a major role in model-based development and serve as a powerful tool to provide quantitative justification for key decision makings during the drug-development process. In this talk, experiences with utilizing exploratory biomarker and exposure-response analyses to aid dose selection and study designs will be shared. The associated statistical and operational challenges will be discussed.
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Authors who are presenting talks have a * after their name.
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