Search Results - "Sethuraman, Venkat"

Data science in pharmaceutical R&D: the DISRUPT-DS industry roundtable by Khan, Najat S., Senderovitz, Thomas, Weatherall, James, Branson, Janice, Egersdoerfer, Benedikt, Genevois-Marlin, Eric, Jasti, Sai, Kazi, Mustaqhusain, Kumble, Ranjit, Loerch, Patrick, Rochon, Justine, Sethuraman, Venkat, Studney, Matt, Wu, Xiaoying, Copping, Ryan, Chandran, Priya, Jayatunga, Madura, Jayanth, Dhruv, Meier, Christoph

“…The DISRUPT-DS roundtable, which brings together data science leaders from large pharmaceutical companies, aims to be a forum for sharing experiences and…”
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Data-driven strategies for increasing patient diversity in Bristol Myers Squibb–sponsored US oncology clinical trials by Kuri, Lorena, Setru, Sagar, Liu, Gengyuan, Reed, Diane Moniz, Weigand, David, Surampudi, Aparna, Berger, Susan, Paulucci, David, Rai, Angshu, Sethuraman, Venkat, Vito, Blythe, Kellar-Wood, Helen, Balan, Mariann Micsinai

“…Background/Aims Determining whether clinical trial findings are applicable to diverse, real-world patient populations can be challenging when the full…”
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Comparison of Transcranial Electric Motor and Somatosensory Evoked Potential Monitoring During Cervical Spine Surgery by Hilibrand, Alan S, Schwartz, Daniel M, Sethuraman, Venkat, Vaccaro, Alexander R, Albert, Todd J

“…BACKGROUND:There has been little enthusiasm for somatosensory evoked potential monitoring in cervical spine surgery as a result, in part, of the increased risk…”
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Effects of Rifampin and Ketoconazole on the Pharmacokinetics of Nilotinib in Healthy Participants by Tanaka, Chiaki, Yin, Ophelia Q. P., Smith, Tom, Sethuraman, Venkat, Grouss, Karen, Galitz, Lawrence, Harrell, Robert, Schran, Horst

“…Nilotinib (Tasigna), an orally bioavailable second‐generation BCR‐ABL tyrosine kinase inhibitor, is approved for use in patients with chronic myeloid leukemia…”
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On evaluation of consistency in multi-regional clinical trials by Ying, Lisa, Song, Fuyu, Chow, Shein-Chung, Zeng, Na, Zheng, Jiayin, Li, Xiaodong, Henry, David, Sethuraman, Venkat

“…In recent years, multi-regional clinical trials (MRCT) that conduct clinical trials simultaneously in Asian Pacific region, Europe, and the United States have…”
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Effects of hepatic impairment on the pharmacokinetics of nilotinib: An open-label, single-dose, parallel-group study by Yin, Ophelia Q.P., PhD, FCP, Gallagher, Neil, MD, PhD, Tanaka, Chiaki, PhD, Fisher, Deirdre, BN, Sethuraman, Venkat, PhD, Zhou, Wei, PhD, Lin, Tsu-Han, PhD, Heuman, Douglas, MD, Schran, Horst, PhD

“…Abstract Background: Nilotinib is a second-generation BCR-ABL tyrosine kinase inhibitor approved for the treatment of patients who have imatinib-resistant…”
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Evaluation of vardenafil and sildenafil on cardiac repolarization by Morganroth, Joel, Ilson, Bernard E, Shaddinger, Bonnie C, Dabiri, Guissou A, Patel, Bela R, Boyle, Duane A, Sethuraman, Venkat S, Montague, Timothy H

“…This novel study evaluated the effects of vardenafil and sildenafil on QT and corrected QT (QTc) duration using a model that minimizes experimental error to…”
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Sample size calculation for the Power Model for dose proportionality studies by Sethuraman, Venkat S., Leonov, Sergei, Squassante, Lisa, Mitchell, Toni R., Hale, Michael D.

“…There are several approaches to assess or demonstrate pharmacokinetic dose proportionality. One statistical method is the traditional ANOVA model, where dose…”
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Accelerating drug development at Bristol Myers Squibb through innovation by Viraswami-Appanna, Kalyanee, Buenconsejo, Joan, Baidoo, Charlotte, Chan, Ivan, Li, Daniel, Micsinai-Balan, Mariann, Tiwari, Ram, Yang, Ling, Sethuraman, Venkat

“…•Innovative methods are needed to boost productivity and accelerate the development of drugs.•Innovative efforts are focused on the adoption of innovative…”
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Women on the Chopping Block? Gender Dynamics on the Popular Food Network Show by Jalalzai, Farida, Sethuraman, Venkat, Sethuraman, Maya

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Emulating Randomized Controlled Trials with Hybrid Control Arms in Oncology: A Case Study by Sengupta, Sanhita, Ntambwe, Ives, Tan, Katherine, Liang, Qixing, Paulucci, David, Castellanos, Emily, Fiore, Joseph, Lane, Stephen, Micsinai Balan, Mariann, Viraswami‐Apanna, Kalyanee, Sethuraman, Venkat, Samant, Meghna, Tiwari, Ram

“…This proof‐of‐concept study retrospectively assessed the feasibility of applying a hybrid control arm design to a completed phase III randomized controlled…”
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Impact of baseline ECG collection on the planning, analysis and interpretation of 'thorough' QT trials by Sethuraman, Venkat, Sun, Qiankun

“…The current guidelines, ICH E14, for the evaluation of non‐antiarrhythmic compounds require a ‘thorough’ QT study (TQT) conducted during clinical development…”
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On Power and Sample Size Calculation in Ethnic Sensitivity Studies by Zhang, Wei, Sethuraman, Venkat

“…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…”
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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 by Young, Tina C., Srinivasan, Subasree, Vetter, Marion L., Sethuraman, Venkat, Bhagwagar, Zubin, Zwirtes, Ricardo, Narasimhan, Premkumar, Chuang, Tilda, Smyth, Brendan J.

“…A systematic review of the Bristol‐Myers Squibb normal healthy volunteers (NHVs) database identified phase 1 trials that included NHVs administered placebo…”
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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: Journal of Clinical Pharmacology by Young, Tina C., Srinivasan, Subasree, Vetter, Marion L., Sethuraman, Venkat, Bhagwagar, Zubin, Zwirtes, Ricardo, Narasimhan, Premkumar, Chuang, Tilda, Smyth, Brendan J.

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

“…The application of modeling and simulation (M&S) methods to improve decision-making was discussed during the Trends & Innovations in Clinical Trial Statistics…”
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Balanced 2n Factorial Designs When Observations are Spatially Correlated by Sethuraman, Venkat, Raghavarao, Damaraju

“…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…”
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Balanced 2(n) factorial designs when observations are spatially correlated by Sethuraman, Venkat, Raghavarao, Damaraju

“…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…”
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Balanced 2 n Factorial Designs When Observations are Spatially Correlated by Sethuraman, Venkat, Raghavarao, Damaraju

“…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…”
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Statistical Consideration in Testing for Assay Sensitivity in a Thorough QT Study by Sethuraman, Venkat, Wu, Shuang, Wang, Jixian

“…The current guidelines, ICH E14, for the evaluation of non-antiarrhythmic compounds recommends a "thorough" QT study (TQT) to be conducted during clinical…”
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