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http://dx.doi.org/10.4333/KPS.2010.40.1.001

Development of BioEquiv, a Computer Program for the Analysis of Bioequivalence  

Yoon, Sang-Hoo (Department of Statistics, Chonnam National University)
Hwang, Nan-A (Team of University-Industry Cooperation Program, National Research Foundation of Korea)
Lim, Young-Chai (Department of Pharmacology, Chonnam National University Medical School)
Lee, Yong-Bok (College of Pharmacy, Chonnam National University)
Park, Jeong-Soo (Department of Statistics, Chonnam National University)
Publication Information
Journal of Pharmaceutical Investigation / v.40, no.1, 2010 , pp. 1-7 More about this Journal
Abstract
K-$BEtest^{(R)}$ is a well known program for bioequivalence test using a $2{\times}2$ design. Lee et al.(1998) and Park et al.(1999) suggested a $3{\times}3$ and $3{\times}2$ design, and also discussed their benefits. We developed a computer program, called BioEquiv, which can analyze some complex experimental designs such as, $3{\times}3$ design and $3{\times}2$ design including a standard $2{\times}2$ design. This program is a user-friendly one and overcomes the disadvantages of K-$BEtest^{(R)}$. The detailed statistical formula and structure of BioEquiv are presented with some examples. The comparison between K-$BEtest^{(R)}$ and BioEquiv are given with actual data analysis. BioEquiv is able to present a table of ANOVA test over some complex experimental designs. Moreover K-$BEtest^{(R)}$ and BioEquiv draw the same result when data consists of $2{\times}2$ design.
Keywords
Bioeqivalence; Computer program; Design of experiments; Statistical test;
Citations & Related Records
Times Cited By KSCI : 4  (Citation Analysis)
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1 W.J. Westlake, The use of balanced incomplete block designs in comparative bioavailability trials, Biometrics, 30(2), 319-327 (1974).   DOI
2 식품의약품안전청 고시 제 2008-22호, 생물학적동등성시험기준 (2008.5.7).
3 C.M. Metzler, Bioavailability : A problem in equivalence, Biometrics, 30(2), 309-317 (1974).   DOI
4 이민화, 심창구, 정석재, 약제학실험, 한림원, 서울 (1997).
5 Y.J. Lee, J.H. Choi, S.H. Song, C.H. Seo, D.S. Kim, I.S. Park, K.H. Choi, H.K. Na, S.J. Chung, M.H. Lee and C.K. Shim, “Development of $K-BEtest^{\circledR}$, a computer program for the analysis of bioequivalence, J. Kor. Pharm. Sci., 28(4), 223-229 (1998).   과학기술학회마을
6 권광일, 김옥희, 김종국, 김주일, 배균섭, 사홍기, 이용복, 이화정, 최선옥, 생물학적동등성의 이해, 신일상사, 서울 (2006).
7 Y.J. Lee, M.G. Lee, S.J. Chung, M.H. Lee and C.K. Shim, Statistical analysis of three sequence-three periods bioequivalence study : application to bioequivalence test of ondansetron formulations, J. Kor. Pharm. Sci., 28(1), 35-42. (1998)   과학기술학회마을
8 W.J. Westlake, The design and analysis of comparative blood-level trials, Current Concepts in the Pharmaceutical Sciences, J. Swarbrick(Ed.), Lea & Febiger, Philadelphia (1973).
9 H.S. Oh, S.G. Ko, J.I. Kim and S.G. Park, Assessing bioequivalence with two new drug formulations and a reference formulation, Korean J. Applied Statist., 12(1), 241-251 (1999).   과학기술학회마을
10 S.G. Park, J.I. Kim, S.S. Chae, S.G. Ko, H.S. Oh, W.Y. Yang, D.S. Kim and Y.W. Choi, Statistical analysis of bioequivalence study in $3{\times}2$ crossover design, J. Kor. Pharm. Sci., 28(4), 231-239 (1998).   과학기술학회마을
11 A.L. Henanff, B. Giraudeau, G. Baron and P. Ravaud, Quality of Reporting of Noninferiority and Equivalence Randomized Trials, J. Am. Med. Assoc., 295, 1147-1151(2006).   DOI
12 S. Rani and A. Pargal, Bioequivalence: An overview of statistical concepts, Indian J Pharmacol., 36(4), 209-216 (2004).
13 V.W. Steinijans, Some conceptual issues in the evaluation of average, population, and individual bioequivalence, Drug Information Journal, 35, 893-899 (2001).   DOI
14 S.-C. Chow, J. Shao and H. Wang, Statistical tests for population bioequivalence, Statistica Sinica, 13, 539-554 (2003).