The use of real-world data/evidence in regulatory submissions-Reference-Cited by-同舟云学术

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The use of real-world data/evidence in regulatory submissions

Published:2021-10 Issue: Volume:109 Page:106521
ISSN:1551-7144
Container-title:Contemporary Clinical Trials
language:en
Short-container-title:Contemporary Clinical Trials

Author:

Song Fuyu,Zang Chenxuan,Ma Xinyi,Hu Sifan,Sun Qiqing,Chow Shein-Chung,Sun Hongqiang

Publisher

Elsevier BV

Subject

Pharmacology (medical),General Medicine

Reference11 articles.

1. The 21st century cures act;CCA,2016

2. Different doses of recombinant tissue-type plasminogen activator for acute stroke in Chinese patients;Chao;Stroke.,2014

3. Innovative Methods for Rare Disease Drug Development;Chow,2020

4. Inference for clinical trials with some protocol amendments;Chow;J. Biopharm. Stat.,2005

5. On non-inferiority margin and statistical tests in active control trials;Chow;Stat. Med.,2006

Cited by 4 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. On the use of RWD in support of regulatory submission in drug development;Journal of Biopharmaceutical Statistics;2024-03-19

2. Using real‐world data to predict health outcomes—The prediction design: Application and sample size planning;Biometrical Journal;2023-07-26

3. Drug repurposing using real-world data;Drug Discovery Today;2023-01

4. Completeness and Representativeness of the PHARMO General Practitioner (GP) Data: A Comparison with National Statistics;Clinical Epidemiology;2023-01

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