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Activity Number:
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246
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Type:
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Contributed
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Date/Time:
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Tuesday, August 8, 2006 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #306390 |
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Title:
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Practical Considerations on Lot Acceptance Sampling Procedures
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Author(s):
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Boguang Zhen*+
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Companies:
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U.S. Food and Drug Administration
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Address:
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11413 Duryea Drive, CBER, Potomac, MD, 20854,
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Keywords:
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sampling procedure ; military standard ; operating characteristic curves ; lot release ; binomial distribution
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Abstract:
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To release a biologics product into the market, sampling inspection is required in order to assure the quality of the product. Many organizations adopted the Military Standard Tables for the inspection. Military Standard 105D is a sampling scheme and combines several individual sampling plans in a system designed to motivate the producer to sustain acceptable quality levels. This talk introduces the use of Military Standard and shows its limited use, especially when there is a higher defective rate than expected in lots to be released. A new multiple sampling procedure using the operating characteristic curves and joint binomial distributions is developed as an alternative approach to deal with the limited use of the Military Standard. Considerations of clinical impacts are also taken into accounts when using the new procedure. A real example is presented.
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