JOURNAL BROWSE
Search
Advanced SearchSearch Tips
Detecting an Outlier in 2X2 Bioequivalence Trial
facebook(new window)  Pirnt(new window) E-mail(new window) Excel Download
 Title & Authors
Detecting an Outlier in 2X2 Bioequivalence Trial
Jeong, Gyu-Jin; Park, Sang-Gue; Woo, Hwa-Hyoung;
  PDF(new window)
 Abstract
Outlying or extreme observations are defined to be subject data for which one or more bioavailability measures are discordant with corresponding data for that subject and/or for the rest of the subjects in a study. The presence of outlying observations can have very serious consequences on the conclusions resulting from a bioequivalence study. Two statistical methods are proposed by generalizing the current well known methods and an illustrated example is presented with discussion.
 Keywords
crossover design;bioequivalence;estimates distance;likelihood distance;outlier;
 Language
Korean
 Cited by
1.
건설 프로젝트 특성과 프로젝트 성과 난이도 도출에 관한 연구,조영선;차희성;

한국건설관리학회논문집, 2010. vol.11. 6, pp.78-88 crossref(new window)
2.
건축 프로젝트의 특성을 고려한 성과 난이도 예측 시스템 개발,고영진;차희성;

한국건설관리학회논문집, 2011. vol.12. 1, pp.62-72 crossref(new window)
3.
변이가 큰 약물의 생물학적 동등성 평가에 관한 연구,정규진;박상규;

응용통계연구, 2011. vol.24. 6, pp.1055-1076 crossref(new window)
1.
On Evaluation of Bioequivalence for Highly Variable Drugs, Korean Journal of Applied Statistics, 2011, 24, 6, 1055  crossref(new windwow)
 References
1.
식품의약품안전청 (2008). 생물학적동등성시험기준(제2008-22호)

2.
Bolton, S. (1991). Outliers-Examples and Opinions, Presented at Bioavailability / Bioequivalence: Phar-macokinetic and Statistical Considerations sponsored by Drug Information Association, Bethesda, Maryland

3.
Chow, S. C. and Liu, J. P. (2009). Design and Analysis of Bioavailability and Bioequivalence Studies, 3rd Ed., Chapman & Hall/CRC, Florida

4.
Chow, S. C. and Tse, S. K. (1990). Outlier detection in bioavailability / bioequivalence studies, Statistics in Medicine, 9, 549-558 crossref(new window)

5.
Clayton, D. and Leslie, A. (1981). The bioavailability of erythromycin stearate versus enteric-coated ery-thromycin base when taken immediately before and after food, Journal of International Medical Re-search, 9, 470-477

6.
FDA (2000). Guideline for Industry: Bioavailability and Bioequivalence Studies for Orally Adminis-tered Drug Products? General Considerations, Rockville. Maryland: Center for Drug Evaluation Research, Food and Drug Administration

7.
Ki, F. Y. C., Liu, J. P., Wang, W. and Chow, S. C. (1995). The impact of outlying subjects on decision of bioequivalence, Journal of Biopharmaceutical Statistics, 5, 71-94 crossref(new window)

8.
Liu, J. P. and Weng, C. S. (1991). Detection of outlying data in bioavailability / bioequivalence studies, Statistics in Medicine, 10, 1375-1389 crossref(new window)

9.
Metzler, C. M. and Huang, D. C. (1983). Statistical methods for bioavailability and bioequivalence, Clini-cal Research Practices and Drug Regulatory Affairs, 1, 109-132 crossref(new window)

10.
Ramsay, T. and Elkum, N. (2005). A comparison of four different methods for outlier detection in bioe-quivalence studies, Journal of Biopharmaceutical Statistics, 15, 43-52 crossref(new window)

11.
Rodda, B. E. (1986). Bioequivalence of Solid Oral Dosage Forms, A presentation to the U. S. Food and Drug Administration Hearing on Bioequivalence of Solid Oral Dosage Forms, September 29-October 1, Pharmaceutical Manufacturers Association, Section Ⅲ, 12-15

12.
Wang, W. and Chow, S. C. (2003). Examining outlying subjects and outlying records in bioequivalence trials, Journal of Biopharmaceutical Statistics, 13, 43-56 crossref(new window)