Abstract #301953

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JSM 2002 Abstract #301953
Activity Number: 185
Type: Contributed
Date/Time: Tuesday, August 13, 2002 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section*
Abstract - #301953
Title: Group Sequential Bioequivalence Tests for Non-Systemic Generic Drug Products
Author(s): Joanne (Juan) Zhang*+ and Yi Tsong and Sue-Jane Wang
Affiliation(s): Food and Drug Administration and Food and Drug Administration and Food and Drug Administration
Address: 5600 Fishers Lane, Rockville, MD, 20857, USA
Keywords:
Abstract:

A clinical trial for bioequivalence assessment of a non-systemic generic drug product often consists of two treatment arms (i.e., test and reference treatments) and placebo. In order to make equivalence tests between test and reference treatments meaningful, the experimenter needs to show that both the test and reference treatments are superior to placebo. In a group sequential test setting, after showing that placebo is inferior to both treatments during the inner look, it is only ethical to terminate the placebo arm. Power of the bioequivalence test may be improved over regular group sequential test plan if Bioequivalence testing is performed only after both test and reference treatments are shown to be superior over placebo. It is evaluated with a simulation study.

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Revised March 2002