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Activity Number:
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134
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Type:
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Topic Contributed
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Date/Time:
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Monday, July 30, 2007 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #310309 |
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Title:
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Bioassay: Decisionmaking in the Face of Uncertainty
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Author(s):
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Timothy Schofield*+
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Companies:
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Merck & Co., Inc.
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Address:
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Merck PO Box 4, West Point, PA, 19486,
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Keywords:
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Pharmacuticals ; Bioassay ; Risk
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Abstract:
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Bioassays are utilized in the pharmaceutical industry to monitor and control therapeutic proteins and vaccines. These are important because they are usually linked to the mechanism of activity of the pharmaceutical. Bioassays are subject to variability, which translates into elevated decision risks during development and manufacture. These risks can be minimized through appropriate bioassay design, optimization, and validation. Studies and control strategies utilizing bioassays can be designed to overcome the impact of inherent bioassay variability. This presentation will highlight opportunities to minimize variability, and thereby risk. Bioassay designs such as parallel-line analysis together with randomization, as well as manufacturing and QC models, will be highlighted for mitigating risk to the customer and manufacturer alike.
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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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