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On Evaluation of Bioequivalence for Highly Variable Drugs
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 Title & Authors
On Evaluation of Bioequivalence for Highly Variable Drugs
Jeong, Gyu-Jin; Park, Sang-Gue;
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 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;
 Language
Korean
 Cited by
1.
생물학적 동등성 시험을 위한 2×k 교차설계법의 통계적 고려,노소영;박상규;

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2.
2×k 교차설계법에서 생물학적 동등성 추가시험의 통계적 절차,우화형;박상규;

Journal of the Korean Data and Information Science Society, 2014. vol.25. 6, pp.1181-1193 crossref(new window)
1.
Assessing bioequivalence for highly variable drugs based on 3×3 crossover designs, Korean Journal of Applied Statistics, 2016, 29, 2, 279  crossref(new windwow)
2.
Some Statistical Considerations on 2×k Crossover Designs for Bioequivalence Trial, Korean Journal of Applied Statistics, 2013, 26, 4, 675  crossref(new windwow)
3.
Statistical procedures of add-on trials for bioequivalence in 2×k crossover designs, Journal of the Korean Data and Information Science Society, 2014, 25, 6, 1181  crossref(new windwow)
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