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Volume 29, Issue 5

Journal of Biopharmaceutical Statistics

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Journal of Biopharmaceutical Statistics, Volume 29, Issue 5 (2019)

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Journal of Biopharmaceutical Statistics, Volume 29, Issue 5 (2019)

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Special Issue of 2018 FDA Statistical Conference - Meet the Challenges in Regulatory Science

Articles

Article

Propensity score-integrated power prior approach for incorporating real-world evidence in single-arm clinical studies

Chenguang Wang, Heng Li, Wei-Chen Chen, Nelson Lu, Ram Tiwari, Yunling Xu & Lilly Q. Yue

Pages: 731-748

Published online: 17 Sep 2019

AbstractforPropensity score-integrated power prior approach for incorporating real-world evidence in single-arm clinical studies | Full Text | References | PDF (1.7 MB) | EPUB

2630 Views
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Article

Homogeneity assessment for pivotal medical device clinical studies

Xu Yan, Chul Ahn, Jianxiong Chu, Li Ming Dong, Heng Li, Xuefeng Li, Hong Lu, Nelson Lu, Vandana Mukhi, Rajesh Nair, Ram Tiwari, Yunling Xu & Lilly Q. Yue

Pages: 749-759

Published online: 05 Sep 2019

AbstractforHomogeneity assessment for pivotal medical device clinical studies | Full Text | References | PDF (806.2 KB) | EPUB

603 Views
0 CrossRef citations
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Article

Benefit-risk assessment for binary diagnostic tests

Tianyu Bai, Lan Huang, Meijuan Li & Ram Tiwari

Pages: 760-775

Published online: 09 Sep 2019

AbstractforBenefit-risk assessment for binary diagnostic tests | Full Text | References | PDF (1.2 MB) | EPUB

378 Views
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Article

Adaptive clinical endpoint bioequivalence studies with sample size re-estimation based on a nuisance parameter

Lin Zhu & Wanjie Sun

Pages: 776-799

Published online: 10 Sep 2019

AbstractforAdaptive clinical endpoint bioequivalence studies with sample size re-estimation based on a nuisance parameter | Full Text | References | PDF (2.7 MB) | EPUB

562 Views
4 CrossRef citations
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Article

Estimation on conditional restricted mean survival time with counting process

Junshan Qiu, Ennan Gu, Dali Zhou, John Lawrence, Steven Bai & Hsien Ming J. Hung

Pages: 800-809

Published online: 27 Aug 2019

AbstractforEstimation on conditional restricted mean survival time with counting process | Full Text | References | PDF (1.2 MB) | EPUB

611 Views
3 CrossRef citations
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Article

Performance evaluation of regression splines for propensity score adjustment in post-market safety analysis with multiple treatments

Yuxi Tian, Elande Baro & Rongmei Zhang

Pages: 810-821

Published online: 10 Sep 2019

496 Views
5 CrossRef citations
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Article

Non-inferiority tests for binary endpoints with variable margins

Yixin Ren, Chao Wang, Meiyu Shen & Yi Tsong

Pages: 822-833

Published online: 05 Sep 2019

AbstractforNon-inferiority tests for binary endpoints with variable margins | Full Text | References | PDF (1.2 MB) | EPUB

379 Views
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Article

The use of 95% CI or 90% CI for drug product development — a controversial issue?

Shein-Chung Chow & Jiayin Zheng

Pages: 834-844

Published online: 27 Aug 2019

AbstractforThe use of 95% CI or 90% CI for drug product development — a controversial issue? | Full Text | References | PDF (914.4 KB) | EPUB

726 Views
4 CrossRef citations
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Article

Utilizing shared internal control arms and historical information in small-sized platform clinical trials

Feiran Jiao, Wenda Tu, Sara Jimenez, Victor Crentsil & Yeh-Fong Chen

Pages: 845-859

Published online: 28 Aug 2019

AbstractforUtilizing shared internal control arms and historical information in small-sized platform clinical trials | Full Text | References | PDF (1.7 MB) | EPUB

989 Views
7 CrossRef citations
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Article

Comparing methods for clinical investigator site inspection selection: a comparison of site selection methods of investigators in clinical trials

Nicholas Hein, Elena Rantou & Paul Schuette

Pages: 860-873

Published online: 28 Aug 2019

AbstractforComparing methods for clinical investigator site inspection selection: a comparison of site selection methods of investigators in clinical trials | Full Text | References | PDF (2.2 MB) | EPUB

345 Views
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Article

Statistical considerations for rare diseases drug development

Shein-Chung Chow & Yu-Wei Chang

Pages: 874-886

Published online: 27 Aug 2019

AbstractforStatistical considerations for rare diseases drug development | Full Text | References | PDF (924.6 KB) | EPUB

1115 Views
6 CrossRef citations
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Article

Probability monitoring procedures for sample size determination

Zhipeng Huang & Shein-Chung Chow

Pages: 887-896

Published online: 27 Aug 2019

AbstractforProbability monitoring procedures for sample size determination | Full Text | References | PDF (945.1 KB) | EPUB

454 Views
3 CrossRef citations
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Article

Demonstrating effectiveness or demonstrating not ineffectiveness – A potential solution for rare disease drug product development?

Shein-Chung Chow & Zhipeng Huang

Pages: 897-907

Published online: 27 Aug 2019

AbstractforDemonstrating effectiveness or demonstrating not ineffectiveness – A potential solution for rare disease drug product development? | Full Text | References | PDF (1.3 MB) | EPUB

389 Views
5 CrossRef citations
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Article

Criteria for dose-finding in two-stage seamless adaptive design

Jiayin Zheng & Shein-Chung Chow

Pages: 908-919

Published online: 07 Sep 2019

AbstractforCriteria for dose-finding in two-stage seamless adaptive design | Full Text | References | PDF (1.2 MB) | EPUB

579 Views
1 CrossRef citations
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Article

Simultaneous confidence interval methods for analytical similarity assessment

Jiayin Zheng, Donglei Yin, Mengdie Yuan & Shein-Chung Chow

Pages: 920-940

Published online: 27 Aug 2019

AbstractforSimultaneous confidence interval methods for analytical similarity assessment | Full Text | References | PDF (1.8 MB) | EPUB

299 Views
3 CrossRef citations
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Article

Innovative Thinking on Endpoint Selection in Clinical Trials

Shein-Chung Chow & Zhipeng Huang

Pages: 941-951

Published online: 27 Aug 2019

AbstractforInnovative Thinking on Endpoint Selection in Clinical Trials | Full Text | References | PDF (999 KB) | EPUB

929 Views
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Article

Statistical considerations and impact of the FDA draft guidance for assessing adhesion with transdermal delivery systems and topical patches for ANDAs

Wanjie Sun, Stella Grosser, Carol Kim & Sam G. Raney

Pages: 952-970

Published online: 08 Sep 2019

AbstractforStatistical considerations and impact of the FDA draft guidance for assessing adhesion with transdermal delivery systems and topical patches for ANDAs | Full Text | References | PDF (1.8 MB) | EPUB

374 Views
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Journal of Biopharmaceutical Statistics (Vol.29, Iss.5, 2019)

Special Issue of 2018 FDA Statistical Conference - Meet the Challenges in Regulatory Science

Special Issue of 2018 FDA Statistical Conference - Meet the Challenges in Regulatory Science

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