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Activity Number:
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359
- Contributed Poster Presentations: Biopharmacutical Section
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Type:
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Contributed
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Date/Time:
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Tuesday, July 31, 2018 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #333066
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Title:
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A Novel Outlier Test for Plate Based Dilution Bioassay
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Author(s):
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Jerry W. Lewis*
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Companies:
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Biogen Idec
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Keywords:
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Abstract:
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Outlier testing has a long and checkered history in the pharmaceutical/biopharmaceutical industry, and has undergone close regulatory scrutiny since the Barr decision (U.S.A. vs. Barr Labs, 1993). Beginning from some basic observations on the philosophy and practice of outlier testing this poster will proceed to the development of a novel and more effective outlier test for plate based relative potency dilution bioassays with limited replication.
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Authors who are presenting talks have a * after their name.
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