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Abstract Details
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Activity Number:
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351
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Type:
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Contributed
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Date/Time:
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Tuesday, August 2, 2011 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #303250 |
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Title:
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Statistical Methods and General Principles of Exposure-Response Analysis
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Author(s):
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Rui Tang*+ and Erik Rasmussen and Hongjie Deng and Lisa Hendricks and Mike Hale and Li Chen
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Companies:
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Amgen Inc. and Amgen Inc. and Amgen Inc. and Amgen Inc. and Amgen Inc. and Amgen Inc.
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Address:
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one center amgen drive, thousand oaks, CA, 91320,
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Keywords:
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PK ;
PD ;
exposure response analysis ;
protocol designs
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Abstract:
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Pharmacokinetics (PK) characterizes the absorption, distribution, metabolism, and elimination properties of a drug, while pharmacodynamics (PD) defines the physiological and biological response to the administered drug. Exposure-response analysis seeks to explore and characterize the relationship between these processes. To understand the relationship between drug exposure and efficacy (or safety) response, extensive exposure-response analyses using data from a phase 2 study were conducted. The analyses impacted dose selection for the phase 3 protocol designs. In this presentation, we will summarize the statistical methods and principles for exposure-response analyses. Issues and limitation of these analyses will be indentified and discussed. Experiences with cross-functional collaboration will be shared.
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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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