Abstract #301495

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JSM 2002 Abstract #301495
Activity Number: 198
Type: Topic Contributed
Date/Time: Tuesday, August 13, 2002 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section*
Abstract - #301495
Title: A Review of Equivalence Testing in Clinical Trials
Author(s): Ghanshyam Gupta*+ and Tie-Hua Ng
Affiliation(s): Food and Drug Administration and Food and Drug Administration
Address: 1401 Rockville PIke, Rockville, Maryland, 20852, USA
Keywords: Equivalence Testing ; 50% Rule ; Review
Abstract:

This paper reviews the work in equivalence testing in clinical trials with two treatment groups with reference to the difference of mean or proportions and the ratio of mean and proportions. As an example, it describes how the FDA advisory committee recommendation of maintaining at least 50% of the benefit of the standard therapy versus placebo was utilized in drug approvals. A brief review of the work of several authors in the area of equivalence testing with more than two treatment groups is then given to provide the background for talks that are being presented in the session, "Equivalence Testing Beyond Two Treatment Groups."

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JSM 2002

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Revised March 2002