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Abstract Details
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Activity Number:
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530
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Type:
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Roundtables
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Date/Time:
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Wednesday, August 1, 2012 : 12:30 PM to 1:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304991 |
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Title:
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Existing Practice and New Trends in Bioassay
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Author(s):
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Lev Sirota*+
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Companies:
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FDA
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Address:
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1401 Rockville Pike, Rockville, MD, 20852-1428, United States
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Keywords:
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bioassay
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Abstract:
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Evolution of requirements for bioassays will be discussed in the framework of an assay lifecycle. In particular, the discussion will include the following topics: trends in bioassay terminology and statistical approaches, fitness for use, setting and justification of bioassay specifications, issues in bioassay design, what should be documented in bioassay-related submission to the regulatory agency, how to demonstrate that assay is under control, comparison of bioassays. Some regulatory implications of the new USP bioassay guidance will also be discussed.
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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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