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Journal of Biopharmaceutical Statistics Volume 24, 2014 - Issue 6: Issues in Biosimilar Drug Development
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Original Articles

Equivalence Tests for Interchangeability Based on Two One-Sided Probabilities

Xiaoyu DongOffice of Biostatistics/Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USACorrespondence[email protected]
,
Yi TsongOffice of Biostatistics/Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
&
Meiyu ShenOffice of Biostatistics/Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
Pages 1332-1348 | Received 07 Oct 2013, Accepted 07 May 2014, Published online: 31 Oct 2014

Citations (10)

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Read on this site (1)

Xiaoyu Dong, Yi Tsong, Meiyu Shen & Jinglin Zhong. (2015) Using Tolerance Intervals for Assessment of Pharmaceutical Quality. Journal of Biopharmaceutical Statistics 25:2, pages 317-327.
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Articles from other publishers (9)

Chian Chen & Chin‐Fu Hsiao. (2020) Use of tolerance intervals for assessing biosimilarity. Statistics in Medicine 39:26, pages 3806-3822.
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Keyang Cheng, Fei Tao, Yongzhao Zhan, Maozhen Li & Kenli Li. (2019) Hierarchical attributes learning for pedestrian re-identification via parallel stochastic gradient descent combined with momentum correction and adaptive learning rate. Neural Computing and Applications 32:10, pages 5695-5712.
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Keyang Cheng & Fei Tao. (2018) A Stochastic Parallel Gradient Descent Algorithm for Person Re-identification * . A Stochastic Parallel Gradient Descent Algorithm for Person Re-identification * .
Fei Tao, Keyang Cheng & Jianming Zhang. (2018) Pedestrian Re-identification Based on Hierarchical Attributes Learning via Parallel Stochastic Gradient Descent. Pedestrian Re-identification Based on Hierarchical Attributes Learning via Parallel Stochastic Gradient Descent.
Keyang Cheng, Fei Tao & Jianming Zhang. (2018) A Stochastic Parallel Gradient Descent Algorithem for Pedestrian Re-identification. A Stochastic Parallel Gradient Descent Algorithem for Pedestrian Re-identification.
Javier Ferreira, Ivan Pau, Kaj Lindecrantz & Fernando Seoane. (2017) A Handheld and Textile-Enabled Bioimpedance System for Ubiquitous Body Composition Analysis. An Initial Functional Validation. IEEE Journal of Biomedical and Health Informatics 21:5, pages 1224-1232.
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Mohammad Atiar Rahman, Meiyu Shen, Xiaoyu Dong, Karl K. Lin & Yi Tsong. 2016. Nonclinical Statistics for Pharmaceutical and Biotechnology Industries. Nonclinical Statistics for Pharmaceutical and Biotechnology Industries 19 31 .
Seung-Ho Kang & Wooyoung Shin. (2015) Statistical Assessment of Biosimilarity based on the Relative Distance between Follow-on Biologics in the ( k + 1)-Arm Parallel Design . Communications for Statistical Applications and Methods 22:6, pages 605-613.
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Yang Yu, Steven Teerenstra, Cees Neef, David Burger & Marc Maliepaard. (2015) Investigation into the interchangeability of generic formulations using immunosuppressants and a broad selection of medicines. European Journal of Clinical Pharmacology 71:8, pages 979-990.
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