Results 11 to 20 of about 5,527 (127)

Safety profile of oxcarbazepine: results from a prescription-event monitoring study [PDF]

, 2010
Purpose: To monitor safety of oxcarbazepine, prescribed in primary care in England, using prescription-event monitoring (PEM). Methods: Postmarketing surveillance using observational cohort technique of PEM.
Buggy, Y., Fogg, Carole, Layton, D., Shakir, S.   +3 more
core   +1 more source

Tocilizumab in rheumatoid arthritis: A case study of safety evaluations of a large postmarketing data set from multiple data sources [PDF]

, 2015
ObjectivesTo evaluate the magnitude of serious adverse events (SAEs) observed in postmarketing reports of tocilizumab (TCZ) for rheumatoid arthritis (RA) in relation to SAEs observed in TCZ clinical trials and external epidemiology data.MethodsA total of
Curtis, Jeffrey R., Napalkov, Pavel, Perez-Gutthann, Susana, Porter-Brown, Benjamin, Singh, Natasha, Suissa, Samy, Thompson, Liz   +6 more
core   +1 more source

Trends and characteristics of accidental and intentional codeine overdose deaths in Australia [PDF]

, 2015
Examines trends in codeine-related mortality rates in Australia, and the clinical and toxicological characteristics of codeine-related deaths. Abstract Objectives: To examine trends in codeine-related mortality rates in Australia, and the clinical and ...
Amanda Roxburgh, Eva Saar, Jennifer Pilgrim, Louisa Degenhardt, Lucinda Burns, Suzanne Nielsen, Wayne D Hall   +6 more
core   +1 more source

The US Food and Drug Administration’s expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements [PDF]

, 2018
The United States Food and Drug Administration (FDA) has several regulatory programs and pathways to expedite the development and approval of therapeutic agents aimed at treating serious or life-debilitating conditions. A common feature of these programs
Naci, Huseyin, Ross, Joseph S., Wallach, Joshua D.   +2 more
core   +1 more source

EDDA Study Designs Taxonomy (version 2.0) [PDF]

, 2016
The EDDA Study Designs Taxonomy (v2.0) was developed by the Evidence in Documents, Discovery, and Analytics (EDDA) Group: Tanja Bekhuis (Principal Scientist); Eugene Tseytlin (Systems Developer); Ashleigh Faith (Taxonomist); Faina Linkov (Epidemiologist).
Bekhuis, Tanja, Tseytlin, Eugene
core   +1 more source

Antipsychotics and Torsadogenic Risk: Signals Emerging from the US FDA Adverse Event Reporting System Database [PDF]

, 2013
Background: Drug-induced torsades de pointes (TdP) and related clinical entities represent a current regulatory and clinical burden. Objective: As part of the FP7 ARITMO (Arrhythmogenic Potential of Drugs) project, we explored the publicly available US ...
A Bate, A Clarke, A Pariente, AK Chung, Ariola Koci, B Darpo, BJ Drew, C Meyer-Massetti, DM Roden, DW Hough, E Poluzzi, E Poluzzi, E Poluzzi, E Raschi, E Raschi, Edoardo Spina, Elijah R. Behr, Elisabetta Poluzzi, Emanuel Raschi, EP Puijenbroek van, ER Behr, F Ponti De, F Ponti De, F Rani, Fabrizio De Ponti, GC Alexander, GK Isbister, H Verdoux, J Nielsen, J Papay, K Jolly, K Titier, LC Wittkampf, LS Schneider, Miriam Sturkenboom, NP Tatonetti, P Kannankeril, P Manu, P Vigneault, RC Owens Jr, RR Shah, S Dhillon, S Hennessy, S Kongsamut, S Leucht, SM Straus, Ugo Moretti, W Crumb, W Crumb, WA Ray, WA Ray, WJ Crumb Jr, WP Stephenson, Y Suzuki   +53 more
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Edoxaban: an update on the new oral direct factor Xa inhibitor. [PDF]

, 2014
Edoxaban is a once-daily oral anticoagulant that rapidly and selectively inhibits factor Xa in a concentration-dependent manner. This review describes the extensive clinical development program of edoxaban, including phase III studies in patients with ...
A. John Camm, AC Skanes, AG Turpie, AJ Camm, AK Kakkar, AT Cohen, B Laulicht, BF Gage, BI Eriksson, BI Eriksson, BI Eriksson, BI Eriksson, BS Stambler, C Kearon, CB Granger, CT Ruff, DE Salazar, G Agnelli, G Agnelli, G Lu, G Raskob, G Raskob, H Masumoto, H Zahir, Henri Bounameaux, J Mendell, J Mendell, J Mendell, J Mendell, J Mendell, J Mendell, J Stampfuss, JH Alexander, JI Weitz, JL Mega, K Ogata, KL Furie, LT Grip, M Crowther, M Hori, M Pirmohamed, MR Lassen, MR Lassen, MR Lassen, MR Lassen, MR Patel, MS Bathala, MU Zafar, N Chung, N Matsushima, R Caterina De, R Caterina De, RP Giugliano, S Kaatz, S Schulman, S Schulman, S Schulman, SE Kimmel, SJ Connolly, SJ Connolly, SJ Connolly, SZ Goldhaber, T Fuji, T Fuji, T Fukuda, T Hulle van der, T Mikkaichi, T Wilke, T Yamashita, TI Verhoef, W Mueck, Y Falck-Ytter, Y Kuroda   +72 more
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Enhancing Postmarketing Surveillance of Medical Products With Large Language Models

JAMA Network Open
ImportanceThe Sentinel System is a key component of the US Food and Drug Administration (FDA) postmarketing safety surveillance commitment and uses clinical health care data to conduct analyses to inform drug labeling and safety communications, FDA advisory committee meetings, and other regulatory decisions.
Michael E, Matheny, Jie, Yang, Joshua C, Smith, Colin G, Walsh, Mohammed A, Al-Garadi, Sharon E, Davis, Keith A, Marsolo, Daniel, Fabbri, Ruth R, Reeves, Kevin B, Johnson, Gerald J, Dal Pan, Robert, Ball, Rishi J, Desai   +12 more
openaire   +2 more sources

Phytochemicals in Cancer Therapy: A Structured Review of Mechanisms, Challenges, and Progress in Personalized Treatment

Chemistry &Biodiversity, Accepted Article.
Objective: Cancer remains a global health challenge, necessitating new therapeutic options. Phytochemicals, with diverse chemical structures and biological activities, show promise as anticancer agents. This review explores key phytochemicals, their mechanisms, and their potential integration into cancer therapy.
Alaa A. A. Aljabali, Mohammad A. Obeid, Rasha M. Bashatwah, Esam Qnais, Omar Gammoh, Abdelrahim Alqudah, Vijay Mishra, Yachana Mishra, Mohammad Ahmed Khan, Suhel Parvez, Mohamed El-Tanani, Taher Hatahet   +11 more
wiley   +1 more source

Improving Drug Safety: The Importance of Postmarking Drug Surveillance [PDF]

, 2004
Improved postmarketing surveillance system may reduce the number of adverse reactions to prescription drugs that under the current system continue to rise as the number of prescriptions written in the U.S ...
James Nyberg, Robert N. Butler
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