Zobrazeno 1 - 10
of 27
pro vyhledávání: '"Névine Zariffa"'
Autor:
Jaap Mandema, Hugh Montgomery, Louis Dron, Shuai Fu, Estelle Russek‐Cohen, Christina Bromley, Samer Mouksassi, Amy Lalonde, Aaron Springford, Larry Tsai, Phil Ambery, Doug McNair, Nawab Qizilbash, Stuart Pocock, Névine Zariffa
Publikováno v:
Clinical and Translational Science, Vol 16, Iss 10, Pp 1842-1855 (2023)
Abstract Rapid and robust strategies to evaluate the efficacy and effectiveness of novel and existing pharmacotherapeutic interventions (repurposed treatments) in future pandemics are required. Observational “real‐world studies” (RWS) can repor
Externí odkaz:
https://doaj.org/article/ae5af344ee23415d9c88b41225ccf99f
Autor:
Diana Merino Vega, Katherine K. Nishimura, Névine Zariffa, Jeffrey C. Thompson, Antje Hoering, Vanessa Cilento, Adam Rosenthal, Valsamo Anagnostou, Jonathan Baden, Julia A. Beaver, Aadel A. Chaudhuri, Darya Chudova, Alexander D. Fine, Joseph Fiore, Rachel Hodge, Darren Hodgson, Nathan Hunkapiller, Daniel M. Klass, Julie Kobie, Carol Peña, Gene Pennello, Neil Peterman, Reena Philip, Katie J. Quinn, David Raben, Gary L. Rosner, Mark Sausen, Ayse Tezcan, Qi Xia, Jing Yi, Amanda G. Young, Mark D. Stewart, Erica L. Carpenter, Charu Aggarwal, Jeff Allen
Publikováno v:
JCO precision oncology. 6
PURPOSE As immune checkpoint inhibitors (ICI) become increasingly used in frontline settings, identifying early indicators of response is needed. Recent studies suggest a role for circulating tumor DNA (ctDNA) in monitoring response to ICI, but uncer
Autor:
Névine Zariffa, Estelle Russek-Cohen
Publikováno v:
Therapeutic Innovation & Regulatory Science
Every medical product requires additional study even after regulatory approval. We highlight several lines of enquiry to advance our understanding of COVID19 vaccines post authorization: identifying key population segments warranting more study, asse
Autor:
Fanni Natanegara, Névine Zariffa, Joan Buenconsejo, null Ran Liao, Freda Cooner, Divya Lakshminarayanan, Samiran Ghosh, Jerald S. Schindler, Margaret Gamalo
Publikováno v:
Statistics in Biopharmaceutical Research
The COVID-19 pandemic presents unprecedented challenges for drug developers seeking to evaluate the safety and efficacy of potential treatments for COVID-19. Clinical researchers must work quickly ...
Publikováno v:
Therapeutic Innovation & Regulatory Science
Publikováno v:
Drug Information Journal. 39:437-445
The International Conference on Harmonisation E14 (2004) calls for public comment by statisticians on the practical implications of the proposed guidance to monitor for QTc prolongation. Of particular interest is consideration of the statistical prop
Autor:
Steven A. Julious, Névine Zariffa
Publikováno v:
Pharmaceutical Statistics. 1:45-53
This is a teaching paper intended as a quick introduction to some of the key concepts in the design of pharmaceutical trials for those new to the industry. Since the first ‘modern’ randomized clinical trial was reported in 1948 by the Medical Res
Publikováno v:
European Journal of Clinical Pharmacology. 57:663-670
Objective: To demonstrate average bioequivalence, the ninety-percent confidence intervals (CI) on the ratio of geometric means for area under the concentration–time curve (AUC) and maximum observed plasma concentration (Cmax) must lie within 0.80
Autor:
Névine Zariffa, Bernard E. Ilson, David E. Martin, David Lundberg, Steve Boike, Duane A. Boyle, Diane K. Jorkasky, John Jushchyshyn, David Tenero
Publikováno v:
Biopharmaceutics & Drug Disposition. 19:351-356
Eighteen healthy males received a single 300 mg oral dose of eprosartan as the commercial wet granulation formulation under fasting conditions and following a high-fat breakfast and a single 20 mg intravenous (i.v.) dose. The pharmacokinetics of i.v.
Autor:
David E. Martin, David Tenero, Diane K. Jorkasky, Bernard E. Ilson, Ann K. Miller, Steven C. Boike, Névine Zariffa
Publikováno v:
British Journal of Clinical Pharmacology. 46:267-270
Aims To compare the pharmacokinetics of eprosartan between young (18-45 years) and elderly (65 years) men and between young men and young, premenopausal women (18-45 years). Methods Twenty-four subjects (eight subjects/group) received a single 200 mg