Results 51 to 60 of about 25,471 (263)

Characteristics of Phase IV Clinical Trials in Oncology: An Analysis Using the ClinicalTrials.gov Registry Data

Current Oncology, 2023
The present study analyzed the characteristics of phase IV clinical trials in oncology using data from the ClinicalTrials.gov registry. The included trials were conducted between January 2013 and December 2022 and were examined for key characteristics ...
Brandon Michael Henry, Giuseppe Lippi, Ameen Nasser, Patryk Ostrowski   +3 more
doaj   +1 more source

Postmarketing safety surveillance data reveals antidepressant effects of botulinum toxin across various indications and injection sites

Scientific Reports, 2020
The World Health Organization estimates the number of people suffering from depression to be over 264 million. Current monoamine transmission modulating therapeutics, even with proper adherence and acceptable tolerability, are not effective for nearly ...
T. Makunts, M. A. Wollmer, R. Abagyan
semanticscholar   +1 more source

Physicians' Experiences as Patients with Statin Side Effects: A Case Series. [PDF]

, 2017
Physicians are among those prescribed statins and therefore, subject to potential statin adverse effects (AEs). There is little information on the impact of statin AEs on physicians affected by them. We sought to assess the character and impact of statin
Golomb, Beatrice Alexandra, Koslik, Hayley J, Meskimen, Athena Hathaway   +2 more
core   +2 more sources

US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009–2018

medRxiv, 2020
Background/Aims The US Food and Drug Administration outlines clinical studies as postmarketing requirements and commitments to be fulfilled following approval of new drugs and biologics (“therapeutics”).
Joshua J. Skydel, A. Zhang, S. Dhruva, J. Ross, J. Wallach   +4 more
semanticscholar   +1 more source

Development of instrument to report and assess causality of adverse events related to herbal medicines

Vitae
: Background: The use of herbal medicines is justified empirically using ethnopharmacological knowledge, which has limitations. Reports of adverse events (AE) may contribute for safety, quality, and effectiveness assessment.
Patrícia de Carvalho Mastroianni, Fabiana Rossi Varallo, Marília Amaral Costa, Luis Vitor da Silva Sacramento   +3 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   +3 more sources

Efficacy of zonisamide: our experience [PDF]

, 2003
The current overview of zonisamide use and effectiveness is based on both a long-term prospective postmarketing survey and current zonisamide use at the Saitama Medical College, Department of Neuropsychiatry.
Yamauchi, Toshio, Aikawa, Hiroshi
core   +2 more sources

Linked health data for pharmacovigilance in children : Perceived legal and ethical issues for stakeholders and data guardians [PDF]

, 2014
Peer reviewedPublisher ...
Bond, Christine M, Francis, Jill J, Haughney, John, Helms, Peter J, Hopf, Yvonne Marina   +4 more
core   +2 more sources

Postmarketing Safety‐Related Regulatory Actions for New Therapeutic Biologics Approved in the United States 2002–2014: Similarities and Differences With New Molecular Entities

Clinical pharmacology and therapy, 2020
We examined the relationship of regulatory and review characteristics to postmarketing safety‐related regulatory actions for 61 new therapeutic biologics (NTBs) approved between October 1, 2002 and December 31, 2014.
I. Bulatao, E. Pinnow, Brendan F. Day, Sanae Cherkaoui, Manish Kalaria, Sonja Brajovic, G. D. Dal Pan   +6 more
semanticscholar   +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
core