Journal of Biopharmaceutical Statistics, Volume 27, Issue 2 (2017)

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Journal of Biopharmaceutical Statistics, Volume 27, Issue 2 (2017)

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Special Issue on Biosimilarity Assessment, Guest Edited by Victoria Yu-Wei Chang and Laszlo Endrenyi

Articles

Article
Guest editor’s note: Special issue on biosimilarity assessment
Victoria Yu-Wei Chang & Laszlo Endrenyi
Pages: 195-196
Published online: 15 Feb 2017
CitationforGuest editor’s note: Special issue on biosimilarity assessment | Full Text | References | PDF (211.1 KB)
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Article
Development of statistical methods for analytical similarity assessment
Yi Tsong, Xiaoyu Dong & Meiyu Shen
Pages: 197-205
Published online: 31 Jan 2017
AbstractforDevelopment of statistical methods for analytical similarity assessment | Full Text | References | PDF (700.6 KB)
  • 1281 Views
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Article
On the establishment of equivalence acceptance criterion in analytical similarity assessment
Tongrong Wang & Shein-Chung Chow
Pages: 206-212
Published online: 17 Jan 2017
AbstractforOn the establishment of equivalence acceptance criterion in analytical similarity assessment | Full Text | References | PDF (541.5 KB)
  • 456 Views
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Article
Statistical considerations regarding correlated lots in analytical biosimilar equivalence test
Meiyu Shen, Tianhua Wang & Yi Tsong
Pages: 213-219
Published online: 11 Jan 2017
AbstractforStatistical considerations regarding correlated lots in analytical biosimilar equivalence test | Full Text | References | PDF (544.3 KB)
  • 339 Views
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Article
Adjustment for unbalanced sample size for analytical biosimilar equivalence assessment
Xiaoyu (Cassie) Dong, Yu-Ting Weng & Yi Tsong
Pages: 220-232
Published online: 26 Jan 2017
AbstractforAdjustment for unbalanced sample size for analytical biosimilar equivalence assessment | Full Text | References | PDF (1.1 MB)
  • 473 Views
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Article
Sample size requirement in analytical studies for similarity assessment
Shein-Chung Chow, Fuyu Song & He Bai
Pages: 233-238
Published online: 11 Jan 2017
AbstractforSample size requirement in analytical studies for similarity assessment | Full Text | References | PDF (474.3 KB)
  • 449 Views
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Article
Sample size determination for a three-arm equivalence trial of Poisson and negative binomial responses
Yu-Wei Chang, Yi Tsong & Zhigen Zhao
Pages: 239-256
Published online: 31 Mar 2017
AbstractforSample size determination for a three-arm equivalence trial of Poisson and negative binomial responses | Full Text | References | PDF (1.5 MB)
  • 317 Views
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Article
Bioequivalence evaluation of sparse sampling pharmacokinetics data using bootstrap resampling method
Meiyu Shen & Stella G. Machado
Pages: 257-264
Published online: 11 Jan 2017
AbstractforBioequivalence evaluation of sparse sampling pharmacokinetics data using bootstrap resampling method | Full Text | References | PDF (630.5 KB)
  • 480 Views
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Article
On hybrid parallel–crossover designs for assessing drug interchangeability of biosimilar products
Shein-Chung Chow, Fuyu Song & Can Cui
Pages: 265-271
Published online: 31 Jan 2017
AbstractforOn hybrid parallel–crossover designs for assessing drug interchangeability of biosimilar products | Full Text | References | PDF (526.9 KB)
  • 367 Views
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Article
Assessing bioequivalence and drug interchangeability
Meng Chen & Shein-Chung Chow
Pages: 272-281
Published online: 19 Jan 2017
AbstractforAssessing bioequivalence and drug interchangeability | Full Text | References | PDF (866.7 KB)
  • 409 Views
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Article
Statistical evaluation of the scaled criterion for drug interchangeability
Jianghao Li & Shein-Chung Chow
Pages: 282-292
Published online: 23 Jan 2017
AbstractforStatistical evaluation of the scaled criterion for drug interchangeability | Full Text | References | PDF (913 KB)
  • 228 Views
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Article
On safety margin for drug interchangeability
Jiayin Zheng, Shein-Chung Chow & Fuyu Song
Pages: 293-307
Published online: 11 Jan 2017
AbstractforOn safety margin for drug interchangeability | Full Text | References | PDF (1 MB)
  • 275 Views
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Article
Wald tests for variance-adjusted equivalence assessment with normal endpoints
Yue-Ming Chen, Yu-Ting Weng, Xiaoyu Dong & Yi Tsong
Pages: 308-316
Published online: 11 Jan 2017
AbstractforWald tests for variance-adjusted equivalence assessment with normal endpoints | Full Text | References | PDF (748.9 KB)
  • 339 Views
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Article
Exact test-based approach for equivalence test with parameter margin
Xiaoyu (Cassie) Dong, Yuanyuan Bian, Yi Tsong & Tianhua Wang
Pages: 317-330
Published online: 17 Jan 2017
AbstractforExact test-based approach for equivalence test with parameter margin | Full Text | References | PDF (1.2 MB)
  • 328 Views
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Article
On the evaluation of reliability, repeatability, and reproducibility of instrumental evaluation methods and measurement systems
Samir Salah, Shein-Chung Chow & Fuyu Song
Pages: 331-337
Published online: 11 Jan 2017
AbstractforOn the evaluation of reliability, repeatability, and reproducibility of instrumental evaluation methods and measurement systems | Full Text | References | PDF (535.6 KB)
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Article
Ratio of means vs. difference of means as measures of superiority, noninferiority, and average bioequivalence
Wanjie Sun, Stella Grosser & Yi Tsong
Pages: 338-355
Published online: 17 Jan 2017
AbstractforRatio of means vs. difference of means as measures of superiority, noninferiority, and average bioequivalence | Full Text | References | PDF (1.9 MB)
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