This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
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Activity Number:
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17
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Type:
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Topic Contributed
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Date/Time:
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Sunday, August 1, 2010 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #306934 |
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Title:
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The Philosophy and Intent of Stability Shelf Life
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Author(s):
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David Christopher*+
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Companies:
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Merck & Co., Inc.
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Address:
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Merck Research Laboratories, Kenilworth, NJ, 07033,
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Keywords:
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shelf life ;
risk assessment ;
quality standard
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Abstract:
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To expand discussion on the current definition of shelf life, a key problem had to be addressed in that, for clinical research and development, a pharmaceutical product is generally judged on the basis of mean response, while commercial batches are essentially judged by individual results. In addition, perceived expectations of the consumer were also considered. Development of a statistical methodology for estimating shelf life must be done in consideration of the issues and challenges of assessing and managing risk relative to different quality standards.
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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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