This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 256
Type: Contributed
Date/Time: Monday, August 2, 2010 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #309006
Title: A Bootstrap Approach to Estimating Antibody Levels in Case of Non-Normal Data
Author(s): Roger Maansson*+
Companies: Merck & Co., Inc.
Address: , , 19454,
Keywords: clinical trials ; bootstrap ; immunogenicity

In vaccine clinical trials, an analysis of the immunogenicity is commonly performed. Sometimes this is as a supportive analysis to the main efficacy analysis or it is the primary analysis itself. Often in this immunogenicity analysis and estimation one assumes that the distribution of log antibody titers is normally distributed. This poster will seek to investigate a bootstrap approach to a situation where the distribution of log antibody titers appear to be non-normal, e.g. to be bimodal. Different bootstrap methods will be used and a comparison of the resulting estimation will be described.

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