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

생물학적동등성시험을 위한 통계처리 프로그램(BioEquiv)의 개발

  • 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)
  • 윤상후 (전남대학교 통계학과) ;
  • 황난아 (한국연구재단 산학협력지원단) ;
  • 임영채 (전남대학교 의과대학 약리학교실) ;
  • 이용복 (전남대학교 약학대학) ;
  • 박정수 (전남대학교 통계학과)
  • Published : 2010.02.20

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

References

  1. 식품의약품안전청 고시 제 2008-22호, 생물학적동등성시험기준 (2008.5.7).
  2. C.M. Metzler, Bioavailability : A problem in equivalence, Biometrics, 30(2), 309-317 (1974). https://doi.org/10.2307/2529651
  3. 이민화, 심창구, 정석재, 약제학실험, 한림원, 서울 (1997).
  4. 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).
  5. 권광일, 김옥희, 김종국, 김주일, 배균섭, 사홍기, 이용복, 이화정, 최선옥, 생물학적동등성의 이해, 신일상사, 서울 (2006).
  6. 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)
  7. 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).
  8. W.J. Westlake, The use of balanced incomplete block designs in comparative bioavailability trials, Biometrics, 30(2), 319-327 (1974). https://doi.org/10.2307/2529652
  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).
  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).
  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). https://doi.org/10.1001/jama.295.10.1147
  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). https://doi.org/10.1177/009286150103500328
  14. S.-C. Chow, J. Shao and H. Wang, Statistical tests for population bioequivalence, Statistica Sinica, 13, 539-554 (2003).