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Activity Number:
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591
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Type:
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Topic Contributed
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Date/Time:
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Thursday, August 6, 2009 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305697 |
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Title:
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Safety Evaluation of Factor VIII Products: Bayesian Approaches
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Author(s):
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Ghanshyam Gupta*+
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Companies:
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FDA
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Address:
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1401 Rockville Pike, Gaithersburg, MD, 20852,
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Keywords:
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Hemophilia ; Inhibitor ; Safety Evaluation
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Abstract:
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Hemophilia, a rare disease, is treated with Factor VIII to prevent or treat bleeding episodes. Inhibitor development is currently the most serious complication associated with replacement factor VIII therapy. Primary safety endpoint in these patients is considered inhibitor development, again a rare event. In the past, maximum of 1 inhibitor development out of 80 patients was considered to meet the safety criterion by frequentist approach. An alternative rule by using Bayesian approach relaxed the criterion to 2 events out of 80 patients. We will provide a background to different approaches to this problem.
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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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