159
Views
5
CrossRef citations to date
0
Altmetric
Original Articles

Equivalence Test for Two Emax Response Curves

&
Pages 307-315 | Received 01 Aug 2015, Published online: 16 Sep 2016

References

  • Demin, I., Hamrn, B., Luttringer, O., Pillai, G., and Jung, T. (2012), “Longitudinal Model-Based Meta-Analysis in Rheumatoid Arthritis: An Application Toward Model-Based Drug Development,” Clinical Pharmacology and Therapeutics, 92, 352–359.
  • FDA Draft Guidance (2014, May), FDA Draft Guidance on Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product, available at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm397017.pdf.
  • FDA Guidance (2015, April), FDA Guidance on Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, available at http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf.
  • Larson, R., and Edwards, B. H. (2009), Calculus, Belmont, CA: Brooks/Cole.
  • Oehlert, G. W. (1992), “A Note on the Delta Method,” The American Statistician, 46, 27–29.
  • Thomas, N., Sweeney, K., and Somayaji, V. (2014), “Meta-Analysis of Clinical Dose–Response in a Large Drug Development Portfolio,” Statistics in Biopharmaceutical Research, 6, 302–317.

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.