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Journal of Biopharmaceutical Statistics Volume 29, 2019 - Issue 5: Special Issue of 2018 FDA Statistical Conference - Meet the Challenges in Regulatory Science
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Articles

Simultaneous confidence interval methods for analytical similarity assessment

Jiayin ZhengBiostatistics Program, Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USAORCID Iconhttps://orcid.org/0000-0002-5559-6847
ORCID Icon,
Donglei YinDepartment of Applied Mathematics and Statistics, Stony Brook University, Stony Brook, NY, USA
,
Mengdie YuanOffice of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USACorrespondence[email protected]
&
Shein-Chung ChowDepartment of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA
Pages 920-940 | Received 15 Oct 2018, Accepted 08 Jul 2019, Published online: 27 Aug 2019

References

  • Chow, S. C. 2013. Biosimilars, design and analysis of follow-on biologics. New York: Chapman & Hall/CRC Press.
  • Chow, S. C. 2018. Analytical similarity assessment in biosimilar product development. New York: Chapman & Hall/CRC Press.
  • US Food and Drug Administration. 2017. Statistical approaches to evaluate analytical similarity: guidance for industry. Silver Springs, MD: US Department of Health and Human Services.
  • Fisher, R. A. 1930. Inverse probability. Proceedings of the Cambridge Philosophical Society 26:528–535. (Collected Papers 84.). doi:10.1017/S0305004100016297.
  • Fisher, R. A. 1935. The fiducial argument in statistical inference. Annals of Human Genetics 6 (4):391–398.
  • Kang, S. H., and S. C. Chow. 2017. Statistical assessment of biosimilarity based on relative distance between follow-on biologics. Statistics in Medicine 32 (3):382–392. doi:10.1002/sim.5582.
  • Seidenfeld, T. 1992. R. A. Fisher’s fiducial argument and Bayes’ Theorem. Statistical Science. 7(3):358–368. Retrieved from http://www.jstor.org/stable/2246072. doi:10.1214/ss/1177011232.
  • Zheng, J., S. C. Chow, and M. Yuan. 2017. On assessing bioequivalence and interchangeability between generics based on indirect comparisons. Statistics in Medicine 36 (19):2978–2993. doi:10.1002/sim.7326.

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