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Activity Number:
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385
- Biomarkers, Endpoint Validation and Other Topics
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Type:
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Contributed
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Date/Time:
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Thursday, August 12, 2021 : 12:00 PM to 1:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #318772
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Title:
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Statistical Design and Data Analysis for the Effect of the Multiple Doses of a Treatment on Renal Functions Using a Pharmacodynamic Biomarker
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Author(s):
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Meiyu Shen* and Kimberly Smith
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Companies:
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Office of Biostatistics CDER, FDA and FDA
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Keywords:
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statistical noninferiority analysis;
a pharmacodynamic biomarker;
multiple doses
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Abstract:
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Phase 1 trial evaluates the effect of multiple doses of a drug on renal function via measurement of a metabolite clearance in healthy subjects. In this presentation, we discuss the design, power and sample size, and statistical data analysis for this study. In general, we know that renal function will be adversely impaired by the drug intake. We propose a non-inferiority analysis allowing a small decrease of renal function after the drug take.
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Authors who are presenting talks have a * after their name.
