Regional consistency and sample size considerations in a multiregional equivalence trial-Reference-Cited by-同舟云学术

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Regional consistency and sample size considerations in a multiregional equivalence trial

Published:2020-07-27 Issue:6 Volume:19 Page:897-908
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceutical Statistics

Author:

Wu Si‐Cheng¹²^ORCID,Xu Jin‐Fang²,Zhang Xin‐Ji²,Li Zhi‐Wei³,He Jia²

Affiliation:

1. Biostatistics Office of Clinical Research Center Shanghai 9th People's Hospital Shanghai China

2. Department of Health Statistics Second Military Medical University Shanghai China

3. School of Science and Engineering The Chinese University of Hong Kong Shenzhen China

Funder

National Natural Science Foundation of China

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pst.2044

Reference18 articles.

1. Q&A for the ICH E5 Guldeline on ethnic factors in the acceptability of foreign data. Paper presented at: 2006 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human use.

2. ICH I.C.o.H. General principles for planning and design of multi‐regional clinical trials E17;2017.

3. Sample size considerations for Japanese patients in a multi-regional trial based on MHLW guidance

4. Establishing consistency across all regions in a multi-regional clinical trial

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