JSM 2004 - Toronto

Abstract #301085

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Activity Number: 42
Type: Topic Contributed
Date/Time: Sunday, August 8, 2004 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #301085
Title: Statistical Considerations in Biomarker Method Development and Evaluation
Author(s): Viswanath Devanarayan*+
Companies: Eli Lilly and Company
Address: Lilly Research Laboratories, Indianapolis, IN, 46285,
Keywords: model selection ; assay validation ; nonlinear regression ; calibration
Abstract:

An overview of important statistical considerations for some commonly used biomarker methods/assays in pre-clinical and clinical research will be provided. This includes model selection, variability assessment, optimization, performance evaluation and validation, method comparison, parallelism, etc. Careful consideration of the inherent statistical issues can greatly enhance the quality of results and conclusions generated from the biomarker methods. Consequently, there is a growing appreciation in the scientific community for statistical collaboration in these and related topics. Along with some background and overview, the value of applying good statistical thinking and practices in some of these topics will be illustrated with examples.


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Revised March 2004