Comparison of parametric and bootstrap method in bioequivalence test

Korean Journal of Physiology and Pharmacology

Volumn 13, Issue 5, 2009, Pages 367-371

  Ahn, Byung Jin ^a   Yim, Dong Seok ^a  

^a The Catholic University of Korea   (South Korea)

Author keywords

Bioequivalence; Bootstrap; Confidence interval; Nonparametric method

Indexed keywords

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BOOTSTRAPPING; CONFIDENCE INTERVAL; CONTROLLED STUDY; HISTOGRAM; MAXIMUM PLASMA CONCENTRATION; NORMAL DISTRIBUTION; PARAMETRIC TEST;

EID: 70450210987     PISSN: 12264512     EISSN: None     Source Type: Journal    
DOI: 10.4196/kjpp.2009.13.5.367     Document Type: Article

References (12)

1. Bonate PL. Pharmacokinetic-pharmacodynamic modeling and simulation. 1st ed. Springer, New York, p 355-363, 2005.
2. Chow SC. Encyclopedia of biopharmaceutical statistics. 2nd ed. Marcel Dekker, New York, p 83-88, 2003.
3. Efron B, Tibshirani R. An introduction to the bootstrap. Monographs on statistics and applied probability. 1st ed. Chapman & Hall, New York, p 179-201, 372-391, 1993.
4. EMEA. Questions & Answers on the Bioavailability and Bioequivalence Guideline (EMEA/CHMP/EWP/40326/2006) [EMEA Web site], http://www.emea.europa.eu/ pdfs/human/ewp/4032606en.pdf. European Medicines Agency, Evaluation of Medicines for Human Use. Accessed August 10, 2009.
5. FDA. Guidance for industry: Statistical Approaches to Establishing Bioequivalence January 2001 [CDER Web site], http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm070244.pdf. US Food and Drug Administration, Center for Drug Evaluation and Research. Accessed August 10, 2009.
6. Henderson AR. The bootstrap: a technique for data-driven statistics. Using computer-intensive analyses to explore experimental data. Clin Chim Acta 359: 1-26, 2005.
7. Lacey LF, Keene ON, Pritchard JF, Bye A. Common noncompartmental pharmacokinetic variables: are they normally or log-normally distributed? J Biopharm Stat 7: 171-178, 1997.
8. Midha KK, Ormsby ED, Hubbard JW, McKay G, Hawes EM, Gavalas L, McGilveray IJ. Logarithmic transformation in bioequivalence: application with two formulations of perphenazine. J Pharm Sci 82: 138-144, 1993. (Pubitemid 23147739)
9. Pabst G, Jaeger H. Review of methods and criteria for the evaluation of bioequivalence studies. Eur J Clin Pharmacol 38: 5-10, 1990. (Pubitemid 20050802)
10. Patterson SD, Jones B. Bioequivalence and the pharmaceutical industry. Pharmaceut Statist 1: 83-95, 2002.
11. Sprent P, Smeeton NC. Applied nonparametric statistical methods. 3rd ed. Chapman & Hall/CRC, Boca Raton, p 404-437, 2001.
12. Steyn HS, Koeleman HA, Gouws E, Ritschel WA. An approach to select the appropriate statistical method for testing bioequivalence. Int J Clin Pharmacol Ther Toxicol 29: 156-160, 1991.