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Journal of Biopharmaceutical Statistics Volume 27, 2017 - Issue 2: Special Issue on Biosimilarity Assessment, Guest Edited by Victoria Yu-Wei Chang and Laszlo Endrenyi
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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]
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Pages 308-316 | Received 06 Jul 2016, Accepted 15 Oct 2016, Published online: 11 Jan 2017

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Read on this site (2)

Yi-Kuan Tseng & Ken-Ning Hsu. (2021) Study design for a three-arm equivalence clinical trial with binomially distributed outcomes. Journal of Biopharmaceutical Statistics 31:6, pages 736-744.
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Yu-Ting Weng, Yi Tsong, Meiyu Shen & Chao Wang. (2019) A modified Wald test for reference scaled assessment of analytical equivalence. Journal of Biopharmaceutical Statistics 29:6, pages 1068-1081.
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Articles from other publishers (6)

Tomokazu S. Sumida, Shai Dulberg, Jonas C. Schupp, Matthew R. Lincoln, Helen A. Stillwell, Pierre-Paul Axisa, Michela Comi, Avraham Unterman, Naftali Kaminski, Asaf Madi, Vijay K. Kuchroo & David A. Hafler. (2022) Type I interferon transcriptional network regulates expression of coinhibitory receptors in human T cells. Nature Immunology 23:4, pages 632-642.
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Jorge Quiroz, Richard Montes, Heliang Shi & Satrajit Roychoudhury. (2019) A comparative study of confidence intervals to assess biosimilarity from analytical data. Pharmaceutical Statistics 18:3, pages 316-328.
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Tianhua Wang, Yi Tsong & Meiyu Shen. 2019. Pharmaceutical Statistics. Pharmaceutical Statistics 27 43 .
Kejian Wu, Haitao Pan, Chen Li, Qingbo Zhao, Ling Wang & Jielai Xia. (2018) An evaluation roadmap for critical quality attributes from tier 1 in analytical similarity assessment. PLOS ONE 13:12, pages e0208354.
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Meiyu Shen & Lixin (Leo) Xu. (2017) Design and statistical analysis of method transfer studies for biotechnology products. Bioanalysis 9:8, pages 595-600.
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Yi Tsong, Qi Xia & Yu-Ting Weng. (2016) Commentary on “Statistical Approaches to Assess Biosimilarity from Analytical Data” by Burdick et al [1]. The AAPS Journal 19:1, pages 15-17.
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