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Activity Number:
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537
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Type:
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Invited
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Date/Time:
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Thursday, August 6, 2009 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #303186 |
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Title:
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Leveraging Exposure Response Information for Efficient Drug Development: Impact of Pharmacometrics
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Author(s):
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Pravin R. Jadhav*+
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Companies:
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FDA
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Address:
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10903 New Hampshire Avenue, Rm 3117, Silver Spring, MD, 20993,
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Keywords:
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pharmacometrics ; pharmacokinetics ; pharmacodynamics ; model based drug development ; exposure-response ; Innovation and Stagnation
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Abstract:
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The cost of drug development has continued to soar and productivity has continued to decrease. Little has changed in drug development over 3 decades despite many promising innovations. The FDA is urging pharmaceutical businesses to be more efficient and productive to facilitate the overall drug development process. One of the critical pathways, the white paper titled "Innovation and Stagnation" depends heavily on the field called pharmacometrics, an area integrating clinical pharmacology, pharmacokinetics, pharmacodynamics, and statistics to enhance model based drug development. The value of this approach in drug development and regulatory review is increasingly being appreciated. Case studies will be presented to demonstrate various methods used and issues encountered in utilizing exposure-response information to aid in clinical drug development and regulatory decisionmaking.
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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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