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Abstract Details
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Activity Number:
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343
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Type:
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Contributed
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Date/Time:
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Tuesday, July 31, 2012 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #306310 |
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Title:
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Group Sequential Method for PK Bioequivalence Crossover Studies
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Author(s):
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Huaixiang Li*+ and Stella Grosser
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Companies:
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FDA/OTS/CDER/OB/DBG and FDA/CDER
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Address:
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20913 Severndale Terrace, Germanton, MD, 20876, United States
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Keywords:
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PK Bioequivalence test ;
interim analysis ;
geometric mean ratio ;
coefficient of variation
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Abstract:
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Bioequivalence of two drug products is usually assessed using a single-stage cross-over study and analyzing the pharmacokinetic parameters AUCt, AUCinf, and Cmax of the products. A two-stage, group-sequential cross-over study design, measuring these same parameters, has been proposed instead. Our simulation shows that the power for the two-stage design is generally lower than the power for the regular one-stage design; this discrepancy increases with increasing within-patient coefficient of variation (CV).
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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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