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

Estimation and Approximation Approaches for Biosimilar Index Based on Reproducibility Probability

Lan-Yan YangBiostatistics and Informatics Unit, Clinical Trial Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan;Gynecologic Cancer Research Center, Clinical Trial Center, Chang Gung Memorial Hospital, Taoyuan, TaiwanCorrespondence[email protected]
&
Chyong-Huey LaiDivision of Gynecologic Oncology, Department of Obstetrics and Gynecology, College of Medicine, Chang Gung Memorial Hospital and Chang Gung University, Taoyuan, Taiwan
Pages 1298-1311 | Received 29 Oct 2013, Accepted 07 May 2014, Published online: 31 Oct 2014

Citations (5)

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Read on this site (1)

Junhui Park & Seung-Ho Kang. (2022) The determination of biosimilarity margin and the assessment of biosimilarity for an -arm parallel design. Communications in Statistics - Theory and Methods 51:2, pages 387-403.
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Articles from other publishers (4)

Ryuji Uozumi & Chikuma Hamada. (2017) Adaptive Seamless Design for Establishing Pharmacokinetic and Efficacy Equivalence in Developing Biosimilars. Therapeutic Innovation & Regulatory Science 51:6, pages 761-769.
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Sarfaraz Niazi. 2015. Biosimilars and Interchangeable Biologics. Biosimilars and Interchangeable Biologics 123 174 .
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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Daniele De Martini. (2018) Reproducibility Probability Testing Kills P-value. SSRN Electronic Journal.
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