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Simultaneous confidence interval methods for analytical similarity assessment.

Publication ,  Journal Article
Zheng, J; Yin, D; Yuan, M; Chow, S-C
Published in: J Biopharm Stat
2019

In analytical similarity assessment of a biosimilar product, key quality attributes of the test and reference products need to be shown statistically similar. When there were multiple references, similarity among the reference products is also required. We proposed a simultaneous confidence approach based on the fiducial inference theory as an alternative to the pairwise comparison method. Three versions with two types of simultaneous confidence intervals for each version were proposed based on different assumptions of the population variance. We conducted extensive simulation studies to compare the performance of our proposed method and the pairwise method, and provided examples to illustrate the concern of using pairwise method.

Duke Scholars

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Published In

J Biopharm Stat

DOI

EISSN

1520-5711

Publication Date

2019

Volume

29

Issue

5

Start / End Page

920 / 940

Location

England

Related Subject Headings

  • Therapeutic Equivalency
  • Statistics & Probability
  • Random Allocation
  • Humans
  • Confidence Intervals
  • Computer Simulation
  • Biosimilar Pharmaceuticals
  • 4905 Statistics
  • 3214 Pharmacology and pharmaceutical sciences
  • 1115 Pharmacology and Pharmaceutical Sciences
 

Citation

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Zheng, J., Yin, D., Yuan, M., & Chow, S.-C. (2019). Simultaneous confidence interval methods for analytical similarity assessment. J Biopharm Stat, 29(5), 920–940. https://doi.org/10.1080/10543406.2019.1657142
Zheng, Jiayin, Donglei Yin, Mengdie Yuan, and Shein-Chung Chow. “Simultaneous confidence interval methods for analytical similarity assessment.J Biopharm Stat 29, no. 5 (2019): 920–40. https://doi.org/10.1080/10543406.2019.1657142.
Zheng J, Yin D, Yuan M, Chow S-C. Simultaneous confidence interval methods for analytical similarity assessment. J Biopharm Stat. 2019;29(5):920–40.
Zheng, Jiayin, et al. “Simultaneous confidence interval methods for analytical similarity assessment.J Biopharm Stat, vol. 29, no. 5, 2019, pp. 920–40. Pubmed, doi:10.1080/10543406.2019.1657142.
Zheng J, Yin D, Yuan M, Chow S-C. Simultaneous confidence interval methods for analytical similarity assessment. J Biopharm Stat. 2019;29(5):920–940.

Published In

J Biopharm Stat

DOI

EISSN

1520-5711

Publication Date

2019

Volume

29

Issue

5

Start / End Page

920 / 940

Location

England

Related Subject Headings

  • Therapeutic Equivalency
  • Statistics & Probability
  • Random Allocation
  • Humans
  • Confidence Intervals
  • Computer Simulation
  • Biosimilar Pharmaceuticals
  • 4905 Statistics
  • 3214 Pharmacology and pharmaceutical sciences
  • 1115 Pharmacology and Pharmaceutical Sciences