Unified additional requirement in consideration of regional approval for multiregional clinical trials-Reference-Cited by-同舟云学术

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Unified additional requirement in consideration of regional approval for multiregional clinical trials

Published:2017-03-13 Issue:6 Volume:27 Page:903-917
ISSN:1054-3406
Container-title:Journal of Biopharmaceutical Statistics
language:en
Short-container-title:Journal of Biopharmaceutical Statistics

Author:

Teng Zhaoyang¹,Chen Yeh-Fong²,Chang Mark³⁴

Affiliation:

1. Takeda Pharmaceuticals, Cambridge, Massachusetts, USA

2. Division of Biometrics III, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA

3. Department of Biostatistics, Boston University, Boston, Massachusetts, USA

4. Veristat, Southborough, Massachusetts, USA

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/10543406.2017.1289942

Reference19 articles.

1. Assessing consistent treatment effect in a multi-regional clinical trial: a systematic review

2. Decision Rules and Associated Sample Size Planning for Regional Approval Utilizing Multiregional Clinical Trials

3. Trial design issues and treatment effect modeling in multi-regional schizophrenia trials

4. Consideration of regional difference in design and analysis of multi-regional trials

5. Sample size and proportion of Japanese patients in multi-regional trials

Cited by 2 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Cautionary note on regional consistency evaluation in multiregional clinical trials with binary outcomes;Pharmaceutical Statistics;2023-12-20

2. Bayesian multiregional clinical trials using model averaging;Biostatistics;2021-07-23

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