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http://dx.doi.org/10.5351/KJAS.2005.18.1.159

A Comparative Study of Statistical Methods for Population Bioequivalence in 2 X 2 Crossover Design  

Park Sang-Gue (Division of Mathematics and Statistics, Chung-Ang University)
Lim Nam-Kyoo (Department of Information and Statistics, Daejeon University)
Lee Jae-Young (Division of Management Engineering, KAIST Graduate School of Management Seoul)
Kim Byung-Chun (KAIST Graduate School of Management Seoul)
Publication Information
The Korean Journal of Applied Statistics / v.18, no.1, 2005 , pp. 159-171 More about this Journal
Abstract
The US Food and Drug Administration(FDA) recommends that population bioequivalence and individual bioequivalence would be assessed to address the prescribability and switchability between a brand-name drug and its new formulation or generic copy in its 2001 guidance document. The test for population bioequivalence in the latest FDA guidance is recommended in 2 x 4 crossover design, but it turns out to be very conservative. Recently Lee, Shao & Chow(2002), Chow, Shao & Wang(2003) and McNally, Iyer & Mathew(2002) proposed new statistical methods for assessing population bioequivalence between drugs to correct the biasness of current FDA method. Since 2 x 2 crossover experiment is most welcomed design in bioequivalence testing, we adopt their methods to 2 x 2 crossover designs and compare their methodologies with FDA one through the simulation study.
Keywords
Average bioequivalence; Individual bioequivalence; Population bioequivalence; 2 x 2 crossover design; Modified large sample method;
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