Proposals of statistical consideration to evaluation of results for a specific region in multi-regional trials - Asian perspective

Author:

Tsou Hsiao-Hui,Chow Shein-Chung,Lan K. K. Gordon,Liu Jen-pei,Wang Mey,Chern Herng-Der,Ho Low-Tone,Hsiung Chao A.,Hsiao Chin-Fu

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Reference12 articles.

1. Tripartite guidance E5 ethnic factors in the acceptability of foreign data;ICH, International Conference on Harmonisation;The U.S. Federal Register,1998

2. Ministry of Health, Labour and Welfare of Japan 2007

3. ICH, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 2006 http://www.ich.org/LOB/media/MEDIA1194.pdf

4. An approach to rationalize partitioning sample size into individual regions in a multi-regional trial;Kawai;Drug Information Journal,2008

5. Sample size considerations for Japanese patients based on MHLW guidance;Quan;Pharmaceutical Statistics,2010

Cited by 19 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. Hierarchical Generalized Linear Models for Multiregional Clinical Trials;Statistics in Biopharmaceutical Research;2021-01-26

2. Hierarchical Linear Models for Multiregional Clinical Trials;Statistics in Biopharmaceutical Research;2019-09-16

3. Statistical implications of extrapolating the overall result to the target region in multi-regional clinical trials;Communications for Statistical Applications and Methods;2018-07-31

4. Design and Data Analysis of Multiregional Clinical Trials (MRCTs)—Theory and Practice;Biopharmaceutical Applied Statistics Symposium;2018

5. An Analysis of Japanese Patients Enrolled in Multiregional Clinical Trials in Oncology;Therapeutic Innovation & Regulatory Science;2017-03

全球学者库

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"全球学者库"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前全球学者库共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2023 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3