1,309
Views
3
CrossRef citations to date
0
Altmetric
Araştırmalar/Original Papers

Examination of Outliers in Bioequivalence Studies

Biyoeşdeğerlik çalışmalarında aykırı değerlerin incelenmesi

& , MSc
Pages 307-312 | Received 07 May 2012, Accepted 28 Sep 2012, Published online: 08 Nov 2016

References

  • Rodda BE. Bioequivalence of solid oral dosage forms. A Presentation to U.S. Food and Drug Administration Hearing on Bioequivalence of Solid Oral Dosage Forms, Pharmaceutical Manufacturers Association. September 29—October 1, Section III, 1986, p. 12–5.
  • Metzler CM, Huang DC. Statistical methods for bioavailability and bioequivalence. Clin Res Pr Drug Regul Aff 1983; 1(2): 109–32.
  • Chow SC, Tse SK. Outlier detection in bioavailability/bioequivalence studies. Stat Med 1990; 9(5): 549–58.
  • Bolton S. Outliers—examples and opinions. Presented at bioavailability/bioequivalence: Pharmacokinetic and Statistical Considerations sponsored by Drug Information Association, Bethesda, Maryland, August, 1991.
  • Liu JP, Weng CS. Detection of outlying data in bioavailability/bioequivalence studies. Stat Med 1991; 10(9): 1375–89.
  • Wang W, Chow SC. Examining outlying subjects and outlying records in bioequivalence trials. J Biopharm Stat 2003; 13(1): 43–56.
  • Kayaalp SO. Klinik Farmakolojinin Esasları ve Temel Düzenlemeler. 2. Baskı, Ankara: Hacettepe Taş Kitapçılık; 2001. p. 305–47.
  • Food and Drug Administration (FDA). Guidance for industry: Bioavailability and bioequivalence studies for orally administered drug products-general considerations. U.S. Department of Health and Human Services, Center for Drug Evaluation and Research, Rockville, Maryland, March, 2003.
  • Karasoy D, Gündüz İ. Statistical methods in bioequivalence studies and an application. Turkiye Klinikleri J Med Sci 2008; 28(5): 653–62. (Turkish).
  • Anderson S, Hauck WW. Consideration of individual bioequivalence. J Pharmacokinet Biopharm 1990; 18(3): 259–73.
  • Chen ML, Patnaik R, Hauck WW, Schuirmann DJ, Hyslop T, Williams R. An individual bioequivalence criterion: Regulatory considerations. Stat Med 2000; 19(20): 2821–42.
  • Barnett V, Lewis T (editors). Outliers in statistical data. Third ed., John Wiley & Sons; 1994. p. 31–52.
  • Ki FYC, Liu JP, Wang W, Chou SC. The impact of outlying subjects on decision of bioequivalence. J Biopharm Stat 1995; 5(1): 71–94.
  • Beckman RJ, Cook RD. Outlier…s (with discussion). Technometrics 1983; 25(2): 119–49.
  • Cook RD, Weisberg S (editors). Residuals and influence in regression. New York and London: Chapman and Hall, 1982, p. 183–205.
  • Ramsay T, Elkum N. A comparison of four different methods for outlier detection in bioequivalence studies. J Biopharm Stat 2005; 15(1): 43–52.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.