Results 21 to 30 of about 19,507 (228)

Materiovigilance: An Indian perspective

Perspectives in Clinical Research, 2018
Materiovigilance is the coordinated system of identification, collection, reporting, and analysis of any untoward occurrences associated with the use of medical devices and protection of patient's health by preventing its recurrences.
Bikash Ranjan Meher
doaj   +1 more source

Incomplete Resolution of Deep Vein Thromboses during Rivaroxaban Therapy. [PDF]

, 2017
We present the case of a patient with a deep vein thrombosis (DVT) who failed rivaroxaban therapy. Our patient initially presented with left lower extremity edema, erythema, and pain.
Adashek, Jacob, Ben-Zur, Uri M, Nagar, Menachem, Pietras, Richard J, Toomari, Nojan, Yaghoubian, Jonathan M, Yaghoubian-Yazi, Bahareh   +6 more
core   +5 more sources

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

Drug therapeutic failures as a cause of admission to an intensive care unit at a university hospital

Journal of Research in Pharmacy Practice, 2019
Objective: Drug therapeutic failures (TFs) are included in pharmacovigilance reporting, as some authors consider them a type of adverse drug reaction.
Jair Antonio Ruiz-Garzon, Camilo Andrés Rojas-Velandia, Carlos-Alberto Calderon-Ospina   +2 more
doaj   +1 more source

Clinical pharmacology information in regulatory submissions and labeling: A comparative analysis of orphan and non‐orphan drugs approved by the FDA

Clinical and Translational Science, 2022
Clinical pharmacology is an integral discipline supporting the development, regulatory evaluation, and clinical use of drugs for the treatment of both common and rare diseases.
Julie Hsieh, Martina Sahre, Xinning Yang, Rajanikanth Madabushi, Anuradha Ramamoorthy   +4 more
doaj   +1 more source

Improving the external validity of clinical trials: the case of multiple chronic conditions [PDF]

, 2013
The U.S. Department of Health and Human Services vision and strategic framework on multiple chronic conditions (MCCs) incorporates recommendations designed to facilitate research that will improve our knowledge about interventions and systems that will ...
Fortin, Martin, Smith, Susan M.
core   +4 more sources

Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis

BMC Medicine, 2019
Background Postmarketing commitments are clinical studies that pharmaceutical companies agree to conduct at the time of FDA approval, but which are not required by statute or regulation.
Joshua D. Wallach, Anita T. Luxkaranayagam, Sanket S. Dhruva, Jennifer E. Miller, Joseph S. Ross   +4 more
doaj   +1 more source

On the evidence consistency of pharmacovigilance outcomes between Food and Drug Administration Adverse Event Reporting System and electronic medical record data for acute mania patients

Health Informatics Journal, 2020
Evaluation of premarketing drug safety in clinical trials is often limited, due to the relatively small sample size and short follow-up time. The data collected in the postmarketing spontaneous reporting systems such as Food and Drug Administration ...
Rui Duan, Xinyuan Zhang, Jingcheng Du, Jing Huang, Cui Tao, Yong Chen   +5 more
doaj   +1 more source

Real-world effectiveness and safety of glecaprevir/pibrentasvir therapy in patients with chronic hepatitis C virus infection in Switzerland

Swiss Medical Weekly, 2021
AIM OF THE STUDY In the era of pangenotypic treatment regimens against hepatitis C virus (HCV) infection, data from postmarketing observational studies are crucial to better understand the treatment patterns used in specific countries and ...
Beat Müllhaupt, David Semela, Lisa Ruckstuhl, Lorenzo Magenta, Olivier Clerc, Ralph Torgler, Francesco Negro, Nasser Semmo   +7 more
doaj   +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
core   +4 more sources