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Activity Number:
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66
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Type:
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Contributed
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Date/Time:
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Sunday, July 29, 2007 : 4:00 PM to 5:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #308478 |
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Title:
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Power and Sample Size for Dose Proportionality Studies
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Author(s):
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Ilsung Chang*+ and Jaya Natarajan+
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Companies:
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Johnson & Johnson PRD and Johnson & Johnson PRD
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Address:
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900 Davidson Road, Piscataway, NJ, 08854, 1000 Route 202, Raritan, NJ, 08869,
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Keywords:
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Dose proportionality ; Power and sample size ; Pharmacokinetics
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Abstract:
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The pharmacokinetics of a compound are defined to be dose-proportional if the AUC and Cmax are proportional to the dose. The analysis of dose proportionality studies can be handled in several ways: ANOVA, confidence intervals for each pair of doses studied (BE approach), or confidence interval on the estimated slope of the regression line. In this presentation, for crossover and parallel group designs, we examine the power and sample size required for the two confidence interval approaches (CI for each pair of doses; CI for the estimated slope) using both closed form expression and simulation approach.
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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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