Advanced search
Publication Cover
Journal of Biopharmaceutical Statistics Volume 27, 2017 - Issue 2: Special Issue on Biosimilarity Assessment, Guest Edited by Victoria Yu-Wei Chang and Laszlo Endrenyi
Submit an article Journal homepage
343
Views
8
CrossRef citations to date
0
Altmetric
Articles

Wald tests for variance-adjusted equivalence assessment with normal endpoints

Yue-Ming ChenDepartment of Biostatistics, The University of Texas School of Public Health, Houston, Texas, USA
,
Yu-Ting WengDivision of Biometrics VI, Office of Biostatistics, CDER, FDA, Silver Spring, Maryland, USA
,
Xiaoyu DongDivision of Biometrics VI, Office of Biostatistics, CDER, FDA, Silver Spring, Maryland, USA
&
Yi TsongDivision of Biometrics VI, Office of Biostatistics, CDER, FDA, Silver Spring, Maryland, USACorrespondence[email protected]
View further author information
Pages 308-316 | Received 06 Jul 2016, Accepted 15 Oct 2016, Published online: 11 Jan 2017

References

  • Ahn, S., Fessler, J. A. (2003). Standard errors of mean, variance, and standard deviation estimators. Technical report 413, Communication and signal Processing Labs. The University of Michigan: 1–2.
  • Dong, X., Bian, Y., Tsong, Y., Wang, T. (2016). Exact test based approach for equivalence test with parameter margin. Journal of Biopharmaceutical Statistics. Advance online publication. doi:10.1080/10543406.2016.1265546
  • Dong, X., Tsong, Y., Shen, M., Zhong, J. (2015). Uisng tolerance intervals for assessment of pharmaceutical quality. Journal of Biopharmaceutical Statistics 25:2Special Issue on Biosimilarity Assessment, 317–327.
  • Farrington, C. P., Manning, G. (1990). Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk. Statistics in Medicine 9(12):1447–1454.
  • FDA Draft Guidance on progesterone. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm209294.pdf
  • Ng, H. K. T., Gu, K., Tang, M. L. (2007). Computational study of tests the difference of two poisson means. Computational Statistics & Data Analysis 51(6):3085–3099.
  • Stucke, K.; Kieser, M., (2013). Sample size calculations for noninferiority trials with Poisson distributed data. Biometrical Journal 55(2Special Issue on Biosimilarity Assessment):203–216.
  • Soetaert, K. (2014). Package rootSolve: roots, gradients and steady-states in R. URL https://cran.r-project.org/web/packages/rootSolve/vignettes/rootSolve.pdf
  • Tsong, Y., Dong, X., Shen, M. (2016). Development of statistical methods for analytical similarity assessment. Journal of Biopharmaceutical Statistics. Advance online publication.

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:

Order Reprints Request Corporate Permissions

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:

Request Academic Permissions

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.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.