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

Sample Size Calculations for the Development of Biosimilar Products

Seung-Ho KangDepartment of Applied Statistics, Yonsei University, Seoul, KoreaCorrespondence[email protected]
&
Yongjo KimDepartment of Applied Statistics, Yonsei University, Seoul, Korea
Pages 1215-1224 | Received 30 May 2013, Accepted 23 May 2014, Published online: 31 Oct 2014

Citations (9)

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Read on this site (4)

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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Michael J. Grayling, Adrian P. Mander & James M. S. Wason. (2019) Two-Stage Adaptive Designs for Three-Treatment Bioequivalence Studies. Statistics in Biopharmaceutical Research 11:4, pages 360-374.
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Seung-Ho Kang. (2016) Avoiding ambiguity with the Type I error rate in noninferiority trials. Journal of Biopharmaceutical Statistics 26:3, pages 452-465.
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Wooyoung Shin & Seung-Ho Kang. (2016) Statistical assessment of biosimilarity based on the relative distance between follow-on biologics for binary endpoints. Journal of Biopharmaceutical Statistics 26:2, pages 227-239.
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Articles from other publishers (5)

Zengjing Chen, Xiaodong Yan & Guodong Zhang. (2023) Strategic two-sample test via the two-armed bandit process. Journal of the Royal Statistical Society Series B: Statistical Methodology.
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Myung Soo Yoo & Donguk Kim. (2020) Statistical tests for biosimilarity based on relative distance between follow-on biologics for ordinal endpoints. Communications for Statistical Applications and Methods 27:1, pages 1-14.
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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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Seung-Ho Kang, Ji-Yong Jung & Seon-Hye Baik. (2015) Sample Size Calculations for the Development of Biosimilar Products Based on Binary Endpoints. Communications for Statistical Applications and Methods 22:4, pages 389-399.
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