Výsledky vyhledávání - "Venkat Sethuraman"

On evaluation of consistency in multi-regional clinical trials

Autor: Venkat Sethuraman, David Henry, Lisa Ying, Xiaodong Li, Jiayin Zheng, Fuyu Song, Na Zeng, Shein-Chung Chow

Publikováno v: Journal of Biopharmaceutical Statistics. 28:840-856

In recent years, multi-regional clinical trials (MRCT) that conduct clinical trials simultaneously in Asian Pacific region, Europe, and the United States have become very popular for global pharmaceutical development. The main purpose of multi-region

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1dce63fdda9c22b47b1c6cc6aa26a82e
https://doi.org/10.1080/10543406.2017.1397008

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A Systematic Review and Pooled Analysis of Select Safety Parameters Among Normal Healthy Volunteers Taking Placebo in Phase 1 Clinical Trials

Autor: Marion L. Vetter, Ricardo Zwirtes, Zubin Bhagwagar, Subasree Srinivasan, Venkat Sethuraman, Tilda Chuang, Tina C. Young, Brendan J. Smyth, Premkumar Narasimhan

Publikováno v: The Journal of Clinical Pharmacology. 57:1079-1087

A systematic review of the Bristol-Myers Squibb normal healthy volunteers (NHVs) database identified phase 1 trials that included NHVs administered placebo with the aim of characterizing normal inter- and intraindividual safety parameter variability.

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::b5c116cf095b551fc52db5a50fbde902
https://doi.org/10.1002/jcph.913

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Use of statistical and pharmacokinetic–pharmacodynamic modeling and simulation to improve decision-making: A section summary report of the trends and innovations in clinical trial statistics conference

Autor: Venkat Sethuraman, Matthew Hutmacher, Seth Berry, Nitin Mehrotra, Holly Kimko, Michael O'Kelly

Publikováno v: Journal of Biopharmaceutical Statistics. 27:554-567

The application of modeling and simulation (MS) methods to improve decision-making was discussed during the TrendsInnovations in Clinical Trial Statistics Conference held in Durham, North Carolina, USA on May 1-4, 2016. Uses of both pharmacometric an

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::da53882b1c5fb071cde357b89e4db6c0
https://doi.org/10.1080/10543406.2017.1289956

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On Power and Sample Size Calculation in Ethnic Sensitivity Studies

Autor: Wei Zhang, Venkat Sethuraman

Publikováno v: Journal of Biopharmaceutical Statistics. 21:18-23

In ethnic sensitivity studies, it is of interest to know whether the same dose has the same effect over populations in different regions. Glasbrenner and Rosenkranz (2006) proposed a criterion for ethnic sensitivity studies in the context of differen

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https://doi.org/10.1080/10543406.2010.494266

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Clinical Pharmacokinetics of the BCR–ABL Tyrosine Kinase Inhibitor Nilotinib

Autor: Horst Schran, Thomas M. Smith, K. Grouss, Venkat Sethuraman, Hagop M. Kantarjian, X Wang, Francis J. Giles, Chiaki Tanaka, Ophelia Q. P. Yin, Lawrence Galitz, Oliver G. Ottmann

Publikováno v: Clinical Pharmacology & Therapeutics. 87:197-203

This article describes studies that investigated the pharmacokinetics of nilotinib, a highly specific, oral, second-generation BCR-ABL tyrosine kinase inhibitor. After a once- or twice-daily regimen at doses ranging from 50 to 1,200 mg/day in 119 pat

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https://doi.org/10.1038/clpt.2009.208

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Impact of baseline ECG collection on the planning, analysis and interpretation of ‘thorough’ QT trials

Autor: Venkat Sethuraman, Qiankun Sun

Publikováno v: Pharmaceutical Statistics. 8:113-124

The current guidelines, ICH E14, for the evaluation of non-antiarrhythmic compounds require a ‘thorough’ QT study (TQT) conducted during clinical development (ICH Guidance for Industry E14, 2005). Owing to the regulatory choice of margin (10 ms),

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::aa30992e9d40d3dbf6bf116c4df960d3
https://doi.org/10.1002/pst.338

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Balanced 2 n Factorial Designs When Observations are Spatially Correlated

Autor: Damaraju Raghavarao, Venkat Sethuraman

Publikováno v: Journal of Biopharmaceutical Statistics. 19:332-344

In this article we focus on the optimal factorial and fractional-factorial designs when observations within blocks are correlated. The topic was motivated by a problem when the pharmaceutical experimenter needed to develop a controlled release, once-

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::734bb513722addfb9478b25aff0a7eb9
https://doi.org/10.1080/10543400802622543

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Effects of hepatic impairment on the pharmacokinetics of nilotinib: An open-label, single-dose, parallel-group study

Autor: Neil Gallagher, Chiaki Tanaka, Douglas M. Heuman, Ophelia Q. P. Yin, Deirdre Fisher, Venkat Sethuraman, Horst Schran, Tsu-Han Lin, Wei Zhou

Publikováno v: Clinical Therapeutics. 31:2459-2469

Background: Nilotinib is a second-generation BCR-ABL tyrosine kinase inhibitor approved for the treatment of patients who have imatinib-resistant Philadelphia chromosome-positive chronic myeloid leukemia in the chronic or accelerated phase or who are

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https://doi.org/10.1016/j.clinthera.2009.11.015

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Lumbar decompressive surgery

Autor: John M. Beiner, Venkat Sethuraman, Alan S. Hilibrand

Publikováno v: Seminars in Spine Surgery. 15:411-419

Traditionally, decompressive surgery of the lumbar spine has produced successful results in terms of relieving lower extremity radicular pain. In the setting of degenerative disk disease, decompressive surgery is usually performed for lumbar disk her

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::d60b66a2f1d866e32da4eb5a20d7552f
https://doi.org/10.1053/s1040-7383(03)00073-x

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