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Activity Number:
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93
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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 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #308288 |
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Title:
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Design and Analysis of Analytical Method Transfer Studies
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Author(s):
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James Schwenke*+
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Companies:
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Boehringer Ingelheim Pharmaceuticals, Inc.
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Address:
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900 Ridgebury Road, Ridgefield, CT, 06877-0368,
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Keywords:
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method transfer ; equivalence testing ; analysis of variance
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Abstract:
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An analytical method transfer study is a GLP study deigned to demonstrate interlaboratory reproducibility in the transfer of manufacturing. testing or assay processes from one laboratory to another. The typical study involves two laboratories with two analysts within each laboratory, testing samples over a two day period. An equivalence testing strategy is employed to demonstrate the similarity of response obtained by the two laboratories. Depending on the pharmaceutical product involved, different experimentation designs are necessary to accommodate the destructive sampling necessary for testing. Three designs will be discussed, representing independent sampling and variations on split and strip-plot designs. Examples of the analysis corresponding to each design will be presented. Studies involving three or more laboratories will be discussed through examples.
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