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) |
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 , 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 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). |