61
Views
1
CrossRef citations to date
0
Altmetric
Research Article

Statistical Considerations: Alternate Designs and Approaches for Bioequivalence Assessments

&
Pages 119-137 | Published online: 10 Oct 2008

REFERENCES

  • Bolton S, Bon C. Pharmaceutical Statistics4th. Marcel Dekker. 2004
  • Finney D. Statistical Method in Biological Assay3rd. Charles Griffin & Company LTD. 1978; 80–81
  • Guidance. Topical Dermatologic Corticosteroids: In Vivo Bioequivalence. FDA. June 2, 1995
  • Schuirmann DJ. Confidence intervals for the ratio of two means from a crossover study. Proceedings of the Biopharmaceutical Section of the American Statistical Association, Washington, DC, 1989; 121–126
  • Chow SC, Shao J, Wang H. Sample Size Calculations in Clinical Research. Marcel Dekker. 2003; 186–198
  • Summary Basis of Approval, NDA: 21–153 Esomepraole. Clinical Pharmacology and Biopharmaceutics Review. U.S. Food and Drug Administration. 2000
  • Chow SC, Chang M. Adaptive Design Methods in Clinical Trials. Chapman & Hall/CRC. 2007

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.