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Journal of Biopharmaceutical Statistics Volume 20, 2009 - Issue 1: Follow-on Biologics
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Original Articles

Statistical Methods for Assessment of Biosimilarity Using Biomarker Data

Shein-Chung Chow Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina, USA
,
Qingshu Lu Department of Statistics and Finance, University of Science and Technology of China, Anhui, China
,
Siu-Keung Tse Department of Management Sciences, City University of Hong Kong, Hong KongCorrespondence[email protected]
&
Eric Chi Global Biostatistics and Epidemiology, Amgen, Inc., Thousand Oaks, California, USA
Pages 90-105 | Received 01 Dec 2007, Accepted 01 Jun 2009, Published online: 12 Jan 2010

Citations (8)

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Read on this site (2)

Seung-Ho Kang & Yongjo Kim. (2014) Sample Size Calculations for the Development of Biosimilar Products. Journal of Biopharmaceutical Statistics 24:6, pages 1215-1224.
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Hsiao-Hui Tsou, Wan-Jung Chang, Wong-Shian Hwang & Yi-Hsuan Lai. (2013) A Consistency Approach for Evaluation of Biosimilar Products. Journal of Biopharmaceutical Statistics 23:5, pages 1054-1066.
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Articles from other publishers (6)

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.
Crossref
Sarfaraz Niazi. 2015. Biosimilars and Interchangeable Biologics. Biosimilars and Interchangeable Biologics 157 226 .
Sarfaraz Niazi. 2015. Biosimilars and Interchangeable Biologics. Biosimilars and Interchangeable Biologics 81 134 .
Sarfaraz Niazi. 2015. Biosimilars and Interchangeable Biologics. Biosimilars and Interchangeable Biologics 123 174 .
Sarfaraz Niazi. 2015. Biosimilars and Interchangeable Biologics. Biosimilars and Interchangeable Biologics 1 22 .
Sarfaraz K. Niazi. 2014. Handbook of Bioequivalence Testing. Handbook of Bioequivalence Testing 756 787 .

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