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http://dx.doi.org/10.5351/CKSS.2012.19.1.047

Some Remarks on Consistency Test of Add-on Test in Bioequivalence Trials  

Ha, Myoung-Ho (Department of Statistics, Graduate School of Chung-Ang University)
Park, Sang-Gue (Department of Applied Statistics, Chung-Ang University)
Publication Information
Communications for Statistical Applications and Methods / v.19, no.1, 2012 , pp. 47-55 More about this Journal
Abstract
The newly revised bioequivalence guideline of Korea allows the add-on test since July 1, 2008 when the initial bioequivalence trial fails to show the equivalence of two drugs. The statistical model of the add-on test and its two stage testing procedures are discussed. Some statistical points of consistency test in the add-on test are considered and the issue on the sample size of add-on test is discussed. Some reasonable alternative like Japan's guideline for bioequivalence studies is recommended to secure the proper use of an add-on study through some simulation studies.
Keywords
$2{\times}2$ crossover design; add-on test of bioequivalence; consistency test; significance test;
Citations & Related Records
Times Cited By KSCI : 1  (Citation Analysis)
연도 인용수 순위
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