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http://dx.doi.org/10.5351/KJAS.2011.24.6.1055

On Evaluation of Bioequivalence for Highly Variable Drugs  

Jeong, Gyu-Jin (Department of Business Statistics, Hannam University)
Park, Sang-Gue (Department of Applied Statistics, Chung-Ang University)
Publication Information
The Korean Journal of Applied Statistics / v.24, no.6, 2011 , pp. 1055-1076 More about this Journal
Abstract
This paper reviews the definition of highly variable drug(HVD), the present regulatory recommendations and the approaches proposed in the literature to deal with the bioequivalence issues of HVD. The concept and the statistical approach of scaled average bioequivalence(SABE) is introduced and discussed with the current regulatory methods. The recommendations for SABE approach are proposed and the further study topics related to HVDs are also presented.
Keywords
Bioequivalence; highly variable drugs; scaled average bioequivalence;
Citations & Related Records
Times Cited By KSCI : 5  (Citation Analysis)
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