Abstract Details
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Activity Number:
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673
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Type:
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Topic Contributed
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Date/Time:
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Thursday, August 8, 2013 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #308882 |
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Title:
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Bioequivalence Criteria Applied to Dose Proportionality
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Author(s):
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Brian Smith*+
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Companies:
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Amgen, Inc.
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Keywords:
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Dose Proportionality ;
Power Model ;
Bioavailability ;
Pharmacokinetics
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Abstract:
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Traditionally, dose proportionality analyses have been set up to conclude dose proportionality if there is not sufficient evidence to reject a null hypothesis. The problems with an approach like this revolve around analyses that are underpowered. Bioequivalence problems faced similar issues until a confidence interval approach (also referred to as 2 one-sided tests of hypothesis) was introduced. In this approach an x% confidence interval is compared to a predefined interval, (-t, t), and bioequivalence is declared if the confidence interval is completely contained within the pre-defined interval. In this talk, a similar approach is advocated for dose proportionality analysis. Guidance is given on how to choose the predefined interval, and the special characteristics of the power model, ln(C) = a + b*ln(d), will be discussed.
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Authors who are presenting talks have a * after their name.
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