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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 - #304093 |
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Title:
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Bayesian Methods in Lot Release
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Author(s):
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Yunling Xu*+ and Boguang Zhen
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Companies:
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FDA and FDA
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Address:
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CBER, 1401 Rockville Pike, Rockville, MD, 20850,
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Keywords:
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Lot release ; military standard ; consumer's risk ; Bayesian method
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Abstract:
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Sampling inspection is usually required on each individual lot of a biologic product before its release to the market. In a traditional military standard based approach, lot release criterion is manufacturer's risk oriented without explicit consideration of consumer's risk. In this paper, a consumer's risk oriented Bayesian multi-stage sampling approach is proposed. As shown by simulation, the proposed consumer's risk oriented Bayesian approach could achieve similar operating characteristics with smaller sample size comparing to the military standard approach.
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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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