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

Statistical Test for Evaluation of Biosimilarity in Variability of Follow-On Biologics

Tsung-Cheng Hsieh Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina, USA; Division of Biometry, Institute of Agronomy, National Taiwan University, Taipei, TaiwanCorrespondence[email protected]
,
Shein-Chung Chow Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina, USA
,
Jen-pei Liu Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina, USA; Division of Biometry, Institute of Agronomy, National Taiwan University, Taipei, Taiwan
,
Chin-Fu Hsiao Division of Biostatistics and Bioinformatics, National Health Research Institutes, Zhunan, Taiwan
&
Eric Chi Global Biostatistics and Epidemiology, Amgen, Inc., Thousand Oaks, California, USA
Pages 75-89 | Received 01 Mar 2009, Accepted 01 Jun 2009, Published online: 12 Jan 2010

Citations (16)

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Read on this site (5)

Chi-Tian Chen, Hsiao-Hui Tsou, Chin-Fu Hsiao, Yi-Hsuan Lai, Wan-Jung Chang & Jung-Tzu Liu. (2017) A Tolerance Interval Approach to Assessing the Biosimilarity of Follow-On Biologics. Statistics in Biopharmaceutical Research 9:3, pages 286-292.
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Nan Zhang, Jun Yang, Shein-Chung Chow & Eric Chi. (2014) Nonparametric Tests for Evaluation of Biosimilarity in Variability of Follow-on Biologics. Journal of Biopharmaceutical Statistics 24:6, pages 1239-1253.
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Xiaoyu Dong & Yi Tsong. (2014) Equivalence Assessment for Interchangeability Based on Two-Sided Tests. Journal of Biopharmaceutical Statistics 24:6, pages 1312-1331.
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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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Shein-Chung Chow, Laszlo Endrenyi, Peter A Lachenbruch, Lan-Yan Yang & Eric Chi. (2011) Scientific factors for assessing biosimilarity and drug interchangeability of follow-on biologics. Biosimilars 1, pages 13-26.
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Articles from other publishers (11)

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
Shein-Chung Chow & Fuyu Song. 2017. Biosimilar Drug Product Development. Biosimilar Drug Product Development 219 262 .
Laszlo Endrenyi, Paul Declerck & Shein-Chung Chow. 2017. Biosimilar Drug Product Development. Biosimilar Drug Product Development 1 14 .
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 K. Niazi. 2014. Handbook of Bioequivalence Testing. Handbook of Bioequivalence Testing 756 787 .
Shein-Chung ChowLaszlo Endrenyi & Peter A. Lachenbruch. (2013) Comments on the FDA draft guidance on biosimilar products. Statistics in Medicine 32:3, pages 364-369.
Crossref
Tsung-Cheng Hsieh, Shein-Chung ChowLan-Yan YangEric Chi. (2013) The evaluation of biosimilarity index based on reproducibility probability for assessing follow-on biologics. Statistics in Medicine 32:3, pages 406-414.
Crossref
Jun YangNan ZhangShein-Chung ChowEric Chi. (2013) An adapted F -test for homogeneity of variability in follow-on biological products . Statistics in Medicine 32:3, pages 415-423.
Crossref
Nan ZhangJun YangShein-Chung ChowLaszlo Endrenyi & Eric Chi. (2013) Impact of variability on the choice of biosimilarity limits in assessing follow-on biologics. Statistics in Medicine 32:3, pages 424-433.
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