3
Views
3
CrossRef citations to date
0
Altmetric
Research Article

Some Nonparametric Confidence Intervals Are Non-informative, Notably in Bioequivalence Studies

Pages 65-75 | Published online: 28 Sep 2008

References

  • Hauschke D., Steinijans V. W., Diletti E. A distribution-free procedure for the statistical analysis of bioequivalence studies. Int. J. Pharmacol. Ther. Toxicol. 1990; 28: 72–78
  • Hauschke D., Steinijans V. W. Ein verteilungsfreies Verfahren zur statistischen Auswertung von Bioäquivalenzstudien. Biometrie in der chemisch-pharmazeutischen Industrie, Band 5, Statistische Beurteilung der Bioäquivalenz sofort freisetzender Arzneiformen. Gustav Fischer, StuttgartGermany 1991
  • Steinijans V. W., Hauschke D. Update on the statistical analysis of bioequivalence studies. Int. J. Clin. Pharmacol. Ther. Toxicol. 1990; 28: 105–110
  • Wijnand H. P. Bioequivalence revisited: Non-parametric analysis of two-period cross-over studies. Computer Meth. Progr. Biomed. 1993; 40: 249–259
  • Wijnand H. P. Bioequivalence assessment of drug formulations: Non-parametric versus parametric analysis. State University of Leiden, The Netherlands 30 June, 1994, Doctoral thesis
  • U.S. Food and Drug Administration Guidance. Statistical procedures for bioequivalence studies using a standard two-treatment crossover design. 29 June, 1992, Statement under 21 CFR 10.90
  • Commission on the European Communities, CPMP Working Party on Efficacy of Medicinal Products. Note for Guidance, Investigation of Bioavailability and Bioequivalence. December, 1991, III/54/89-EN
  • Wijnand H. P. Updates of bioequivalence programs (including statistical power approximated by Student's t). Computer Meth. Progr. Biomed. 1994; 42: 275–281

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.