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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 - #308938 |
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Title:
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Total Error-Based Criterion for Analytical Method Transfer Analyses
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Author(s):
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Eric Rozet*+ and Walthère Dewe
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Companies:
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University of Liege and GlaxoSmithKline
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Address:
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Av de l Hopital 1 Bat B36, Liege, 4000, Belgium
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Keywords:
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Method transfer ; total error ; beta-expectation tolerance interval
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Abstract:
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The objective of an analytical transfer like for method validation is to give guarantees that a laboratory masters the method of interest. As using total error has been proposed to validate a method, total error-based approaches should be also considered in transferring a method. The major difference in transfer is that only samples from a production lot are used and the sender gives, with some uncertainty, the reference value. Consequently the sender lab penalizes the acceptance limits depending on the precision of the true value estimate. Two approaches are proposed in order to have a total error-based criterion and to take into account the precision of the reference value. Firstly a beta-expectation tolerance interval is calculated and compared to the acceptance limits obtained in the sender lab. Secondly the probability to have a result outside the acceptance limits is estimated.
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