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Statistical Considerations of the Add-On Test on Bioequivalence Trial
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 Title & Authors
Statistical Considerations of the Add-On Test on Bioequivalence Trial
Park, Sang-Gue; Nam, Bong-Hyun; Chung, Yun-Ro; Lee, Jae-Young; Jeong, Gyu-Jin;
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 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;
 Language
Korean
 Cited by
1.
변이가 큰 약물의 생물학적 동등성 평가에 관한 연구,정규진;박상규;

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2.
생물학적 동등성 시험에서 추가시험의 일관성 검정에 대한 소고,하명호;박상규;

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3.
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.
On Evaluation of Bioequivalence for Highly Variable Drugs, Korean Journal of Applied Statistics, 2011, 24, 6, 1055  crossref(new windwow)
2.
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)
 References
1.
식품의약품안전청 (2007). 생물학적 동등성 시험기준(제 2007-65호)

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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.

3.
Chow, S. C. and Liu, J. P. (2008), Design and Analysis of Bioavailability and Bioequivalence Studies, 3rd edition, Chapman & Hall/CRC.