Abstract #300834

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JSM 2002 Abstract #300834
Activity Number: 35
Type: Topic Contributed
Date/Time: Sunday, August 11, 2002 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section*
Abstract - #300834
Title: Defining Equivalence Margin in IVD Equivalence Studies
Author(s): Michael Lu*+
Affiliation(s): Abbott Laboratories
Address: 100 Abbott Park Rd, Abbott Park, Illinois, 60064-6070, USA
Keywords: equivalence study ; IVD ; equivalence margin
Abstract:

Determining an equivalence margin is a challenging task. It is especially challenging for In Vitro Diagnostics (IVD) equivalence studies for two reasons: 1.) the statistical equivalence concept is new to clinicians in the IVD industry; 2.) some product characteristic evaluations do not directly measure the clinical impact of the products. This presentation will propose some statistical tools to assist clinicians in defining an equivalence margin for IVD equivalence studies.

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Revised March 2002