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http://dx.doi.org/10.5351/CKSS.2010.17.1.107

Statistical Considerations of the Add-On Test on Bioequivalence Trial  

Park, Sang-Gue (Department of Statistics, Chung-Ang University)
Nam, Bong-Hyun (International Trade and Statistics Office, Korea Food & Drug Administration)
Chung, Yun-Ro (Department of Biostatistics, University of North Carolina)
Lee, Jae-Young (Business Process Innovation Team(DS), Samsung Electronics Co., Ltd.)
Jeong, Gyu-Jin (Department of Business statistics, Han-Nam university)
Publication Information
Communications for Statistical Applications and Methods / v.17, no.1, 2010 , pp. 107-115 More about this Journal
Abstract
The newly revised bioequivalence guideline of Korea allows the add-on test since July 1, 2008 and some discussion from statistical point of view would be needed for a practical use. The statistical model of add-on test is introduced and its two stage testing procedures are discussed. Meaningful statistical points of the add-on test are delivered through an illustrated example.
Keywords
Add-on test; bioavailability; bioequivalence; consistency;
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  • Reference
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3 Canada Department of Health (1992). Guidance for Industry, Conduct and Analysis of Bioavailability and Bioequivalence Studies - Part A: Oral Dosage Formulations Used for Systemic Effects, Canada.