Zobrazeno 1 - 10
of 10
pro vyhledávání: '"S. Peter Ouyang"'
Autor:
Steven Talerico, S. Peter Ouyang, Ekopimo Ibia, Shailendra Menjoge, Xiaolong Luo, Bruce Binkowitz, Kimitoshi Ikeda, Joshua Chen, Hui Quan, Paul Gallo, Gang Li, Yoko Tanaka
Publikováno v:
Drug Information Journal. 45:603-608
The degree of consistency of treatment effects seen across regions within a multiregional clinical trial has important implications for all stakeholders. It can affect the ability of the trial results to be interpreted by the scientific community in
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::352311505c5fea27b9666e135905f426
https://doi.org/10.1177/009286151104500610
https://doi.org/10.1177/009286151104500610
Autor:
Steven Talerico, Bruce Binkowitz, Shailendra Menjoge, Hui Quan, Gang Li, Yoko Tanaka, Paul Gallo, Joshua Chen, S. Peter Ouyang, Ekopimo Ibia, Kimitoshi Ikeda, Xiaolong Luo
Publikováno v:
Drug Information Journal. 45:595-602
Assessment of consistency of treatment effect across regions is often a key issue in a multiregional clinical trial (MRCT) because of differences in intrinsic and extrinsic factors. Careful consideration of consistency assessment of treatment effect
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::0a0da5f5ccc02974d0c6248122c884e4
https://doi.org/10.1177/009286151104500609
https://doi.org/10.1177/009286151104500609
Publikováno v:
Statistics in Biopharmaceutical Research. 3:1-13
We consider a group sequential design for interim treatment selection where several treatments are compared with a control. Depending on interim treatment comparisons, the number of winners after an interim look is random. In this article, we discuss
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::ab2ab1c851af1fa7a12150bb213bb917
https://doi.org/10.1198/sbr.2011.09051
https://doi.org/10.1198/sbr.2011.09051
Publikováno v:
Pharmaceutical Statistics. 9:179-189
After multi-regional clinical trials (MRCTs) have demonstrated overall significant effects, evaluation for a region-specific effect is often important. Recent guidance (see, e.g. 1) from regulatory authorities regarding evaluation for possible countr
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2c21db1fdf20d89b0a395439ee8ff469
https://doi.org/10.1002/pst.456
https://doi.org/10.1002/pst.456
Publikováno v:
Statistics in Biopharmaceutical Research. 1:366-376
We consider an adaptive design for selecting multiple winner doses at interim in a dose ranging study, evaluating several doses in comparison to placebo. At the end of Stage 1 (interim), we consider four types of decision rules for selecting winner d
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::c6f5dc78abc57668c12499fb1e941049
https://doi.org/10.1198/sbr.2009.0042
https://doi.org/10.1198/sbr.2009.0042
Publikováno v:
Statistics in Biosciences. 1:268-288
We consider hypothesis testing in a clinical trial with an interim treatment selection. Recently, unconditional and conditional procedures for selecting one treatment as the winner have been proposed when the mean responses are approximately normal.
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::d7105a623cef046920faafef1e316ec3
https://doi.org/10.1007/s12561-009-9017-y
https://doi.org/10.1007/s12561-009-9017-y
Autor:
Stephen W. Hall, Willi Kreis, S. Peter Ouyang, Jane Wu, Alton B. Kremer, Donald L. Trump, E. James Seidmon, Michael R. Kurman
Publikováno v:
Annals of Surgical Oncology. 2:550-556
Background: Liarozole binds to the cytochrome P-450-dependent hydroxylating enzymes involved in steroid biosynthesis and retinoic acid catabolism. This phase I study investigated the clinical/endocrine toxicity profile of liarozole and determined the
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3485781af255e4b16946218bd4a6e347
https://doi.org/10.1007/bf02307090
https://doi.org/10.1007/bf02307090
Autor:
Joshua, Chen, Hui, Quan, Bruce, Binkowitz, S Peter, Ouyang, Yoko, Tanaka, Gang, Li, Shailendra, Menjoge, Ekopimo, Ibia
Publikováno v:
Pharmaceutical statistics. 9(3)
A key issue in multi-regional clinical trials (MRCTs) is how to assess the consistency of treatment effect across regions, although there is no a priori reason to believe that the treatment effect should vary across the regions. In this article, we d
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7a3ce77bda550ffd0dbf29fe2f98d9ae
https://pubmed.ncbi.nlm.nih.gov/20872623
https://pubmed.ncbi.nlm.nih.gov/20872623
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