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Activity Number:
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539
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Type:
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Contributed
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Date/Time:
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Thursday, August 2, 2007 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #309215 |
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Title:
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Statistical Challenges in Proof-of-Concept Studies in Photosensitive Epileptics
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Author(s):
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Norman Bohidar*+ and Geoff Edwards and Liwen Xi and Surya Mohanty
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Companies:
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Johnson & Johnson PRD and Johnson & Johnson PRD and Johnson & Johnson PRD and Johnson & Johnson PRD
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Address:
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445 Belle Lane, Harleysville, PA, 19438,
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Keywords:
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Epilepsy ; Proof-of-Concept ; Biomarkers
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Abstract:
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Photosensitive epileptics are commonly used as the target population for Proof-of-Concept studies for Epilepsy drugs. These patients are subjected to Intermittent Photic Stimulation (IPS), and EEG measurements are taken to define their photosensitivity range. Statistical challenges in these types of studies involve (1) deciding on decision rules for determining successful doses, (2) dealing with small sample sizes (3) handling multiple eye conditions and (4) using the responses on this biomarker in this model to predict successful doses in the general epileptic population. In the past, clinical judgment has been used to address these issues. This presentation will propose a statistical framework for evaluating them.
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