Zobrazeno 1 - 9
of 9
pro vyhledávání: '"Soo Peter Ouyang"'
Autor:
Josh Chen, Soo Peter Ouyang, William Wang, Paul Gallo, Weining Z. Robieson, Yoko Tanaka, Bruce Binkowitz, Lanju Zhang, Sammy Yuan, Hui Quan, Gang Li, Gordon Lan
Publikováno v:
Simultaneous Global New Drug Development ISBN: 9781003109785
Simultaneous Global New Drug Development
Simultaneous Global New Drug Development
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::0b393b38b957fcf0b7fef84aa9df2572
https://doi.org/10.1201/9781003109785-9
https://doi.org/10.1201/9781003109785-9
Autor:
Ji Zhang, Bruce Binkowitz, Peng-Liang Zhao, Xuezhou Mao, Mark Chang, Josh Chen, Soo Peter Ouyang, Gang Li, Hui Quan, Yoko Tanaka
Publikováno v:
Contemporary clinical trials. 58
Extensive research has been conducted in the Multi-Regional Clinical Trial (MRCT) area. To effectively apply an appropriate approach to a MRCT, we need to synthesize and understand the features of different approaches. In this paper, examples are use
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::dbcd4d087d3bb2012e96134e4498165b
https://pubmed.ncbi.nlm.nih.gov/28455233
https://pubmed.ncbi.nlm.nih.gov/28455233
Autor:
Ji Zhang, Hui Quan, Joshua Chen, Soo Peter Ouyang, Weichung Joe Shih, Bruce Binkowitz, Peng-Liang Zhao, Xuezhou Mao
Publikováno v:
Statistics in Medicine. 33:2191-2205
We can apply both fixed and random effects models to multi-regional clinical trial (MRCT) design and data analysis. Thoroughly, understanding the features of these models in an MRCT setting will help assessing their applicability to an MRCT. In this
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::f9ade0b43b20de43a9cd045ffdbbf850
https://doi.org/10.1002/sim.6108
https://doi.org/10.1002/sim.6108
Autor:
Ji Zhang, Weichung Joe Shih, Joshua Chen, Mingyu Li, Hui Quan, Soo Peter Ouyang, Peng-Liang Zhao
Publikováno v:
Statistics in Medicine. 32:1691-1706
Multi-regional clinical trials have been widely used for efficient global new drug developments. Both a fixed-effect model and a random-effect model can be used for trial design and data analysis of a multi-regional clinical trial. In this paper, we
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0fa6421020edf434df38b702d78e903b
https://doi.org/10.1002/sim.5543
https://doi.org/10.1002/sim.5543
Autor:
Bruce Binkowitz, Shailendra Menjoge, Soo Peter Ouyang, Kimitoshi Ikeda, Paul Gallo, Mingyu Li, Xiaolong Luo, Joshua Chen, Yoko Tanaka, Hui Quan, Ekapimo Ibia, Steven Talerico, Gang Li
Publikováno v:
Drug Information Journal. 44:617-632
Multiregional clinical trials (MRCTs) present great opportunities but also challenges to the trial community. To address the challenges and fully realize the opportunities, a PhRMA MRCT Cross-Functional Key Issue Team (KIT) was formed in 2008. One of
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::b3741cec57b03bc903a8cd4777f57695
https://doi.org/10.1177/009286151004400509
https://doi.org/10.1177/009286151004400509
Autor:
Xiaolong Luo, Naitee Ting, Bruce Binkowitz, Joshua Chen, Hui Quan, Gang Li, Soo Peter Ouyang, Ekopimo Ibia, Yoko Tanaka, Hao Zheng, Paul Gallo
Publikováno v:
Clinical trials (London, England). 10(6)
Background One key objective of a multi-regional clinical trial (MRCT) is to use the trial results to ‘bridge’ from the global level to local region in support of local registrations. However, data from each individual country are typically limit
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1031711f8d50ab683a3862ccf4f32294
https://pubmed.ncbi.nlm.nih.gov/24013404
https://pubmed.ncbi.nlm.nih.gov/24013404
Autor:
Hui, Quan, Xuezhou, Mao, Joshua, Chen, Weichung Joe, Shih, Soo Peter, Ouyang, Ji, Zhang, Peng-Liang, Zhao, Bruce, Binkowitz
Publikováno v:
Statistics in medicine. 33(13)
We can apply both fixed and random effects models to multi-regional clinical trial (MRCT) design and data analysis. Thoroughly, understanding the features of these models in an MRCT setting will help assessing their applicability to an MRCT. In this
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::26c3cbad0b839b13c6920138eb6db97f
https://pubmed.ncbi.nlm.nih.gov/24515845
https://pubmed.ncbi.nlm.nih.gov/24515845
Publikováno v:
Clinical trials (London, England). 9(3)
Background Unexpected regional difference in treatment effect has been reported in recent multiregional clinical trials (MRCTs). This may cause difficulty in interpreting results and can have regulatory implications such as marketing approvals and/or
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0f47a65575a7cdcc8c7867c873fbc0de
https://pubmed.ncbi.nlm.nih.gov/22436444
https://pubmed.ncbi.nlm.nih.gov/22436444
Autor:
John Van Ryzin, Soo Peter Ouyang
Publikováno v:
Journal of Statistical Planning and Inference. 12:11-25
Let Y1,·,Yn (Y1
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::f949edd52b36d54df403479c4c84f687
https://doi.org/10.1016/0378-3758(85)90049-7
https://doi.org/10.1016/0378-3758(85)90049-7