Some Remarks on Consistency Test of Add-on Test in Bioequivalence Trials Ha, Myoung-Ho; Park, Sang-Gue;
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.
crossover design;add-on test of bioequivalence;consistency test;significance test;
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