Browse > Article
http://dx.doi.org/10.5351/CKSS.2009.16.5.745

Detecting an Outlier in 2X2 Bioequivalence Trial  

Jeong, Gyu-Jin (Department of Business Statistics, Han-Nam University)
Park, Sang-Gue (Department of Statistics, Chung-Ang University)
Woo, Hwa-Hyoung (Department of Statistics, Chung-Ang University)
Publication Information
Communications for Statistical Applications and Methods / v.16, no.5, 2009 , pp. 745-751 More about this Journal
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
$2{\times}2$ crossover design; bioequivalence; estimates distance; likelihood distance; outlier;
Citations & Related Records
연도 인용수 순위
  • Reference
1 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   DOI
2 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
3 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   DOI   ScienceOn
4 Liu, J. P. and Weng, C. S. (1991). Detection of outlying data in bioavailability / bioequivalence studies, Statistics in Medicine, 10, 1375-1389   DOI   ScienceOn
5 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   DOI
6 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   DOI   ScienceOn
7 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
8 Wang, W. and Chow, S. C. (2003). Examining outlying subjects and outlying records in bioequivalence trials, Journal of Biopharmaceutical Statistics, 13, 43-56   DOI   ScienceOn
9 식품의약품안전청 (2008). 생물학적동등성시험기준(제2008-22호)
10 Bolton, S. (1991). Outliers-Examples and Opinions, Presented at Bioavailability / Bioequivalence: Phar-macokinetic and Statistical Considerations sponsored by Drug Information Association, Bethesda, Maryland
11 Chow, S. C. and Liu, J. P. (2009). Design and Analysis of Bioavailability and Bioequivalence Studies, 3rd Ed., Chapman & Hall/CRC, Florida
12 Chow, S. C. and Tse, S. K. (1990). Outlier detection in bioavailability / bioequivalence studies, Statistics in Medicine, 9, 549-558   DOI   ScienceOn