Results 41 to 50 of about 21,353 (254)

Postmarket surveillance: a review on key aspects and measures on the effective functioning in the context of the United Kingdom and Canada

Therapeutic Advances in Drug Safety, 2019
Regulatory approvals for the marketing of medicinal products authorize medical practitioners to prescribe drugs to a group of patients that are defined within the license of the medicinal product.
Nikhil Raj, Swapnil Fernandes, Narayana R. Charyulu, Akhilesh Dubey, Ravi G. S., Srinivas Hebbar   +5 more
doaj   +1 more source

Uncovering Knowledge Gaps in the Safety Profile of Antiangiogenic Drugs in Cancer Patients: Insights from Spontaneous Reporting Systems Studies

Pharmaceuticals, 2023
Global repositories of postmarketing safety reports improve understanding of real-life drug toxicities, often not observed in clinical trials. The aim of this scoping review was to map the evidence from spontaneous reporting systems studies (SRSs) of ...
Valerio Ciccone, Marina Ziche, Andrea Spini, Sandra Donnini   +3 more
doaj   +1 more source

The experience of accommodating privacy restrictions during implementation of a large-scale surveillance study of an osteoporosis medication. [PDF]

, 2016
PurposeTo explore whether privacy restrictions developed to protect patients have complicated research within a 15-year surveillance study conducted with US cancer registries.MethodsData from enrolling 27 cancer registries over a 10-year period were ...
Andrews, Elizabeth B, Deapen, Dennis M, Gilsenan, Alicia W, Harris, David H, Hornicek, Francis J, Midkiff, Kirk D, Schymura, Maria J   +6 more
core   +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

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   +1 more source

Pediatric Developmental Safety Assessment: Are We Ready for the Next Thalidomide?

Clinical Pharmacology &Therapeutics, EarlyView.
Pediatric drug development has achieved remarkable success in the last 20 years with over 1,000 products studied in pediatric patients. This success has been driven in part by an increased understanding of pediatric disease processes. The aspect that has been largely overlooked is the potential adverse effect of new drugs on pediatric developmental ...
Gilbert J. Burckart, Susan M. Abdel‐Rahman, Gelareh Abulwerdi, Sherbet Samuels, Rebecca Racz, Mohamed A. Mohamoud, Nicholas P. Tatonetti   +6 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
core  

Major Adverse Cardiac Events with Ondansetron: A Systematic Review

Clinical Pharmacology &Therapeutics, EarlyView.
Evidence base: 170 randomized trials, 23,421 adults, predominantly single‐dose IV ondansetron, mean follow‐up 20 days. Observed outcomes: Major adverse cardiac events were rare, no ventricular arrhythmias or torsades de pointes observed. Conclusion: Ondansetron was not associated with increased mortality or serious cardiac arrhythmias in adult ...
Michael Cristian Garcia, Bhavya Gandhi, Faisal Quadri, Mahnoor Shahab, Kassie Rong, Genevieve Ramnarine, Ishleen Sudan, Sophia Zhang, Michelle Yu, Sara Mojdehi, Lawrence Mbuagbaw, Anne M. Holbrook   +11 more
wiley   +1 more source

Statin use and the risk of tubulointerstitial nephritis: a real-world signal detection analysis using FDA Adverse Event Reporting System

Frontiers in Medicine
BackgroundStatins are widely prescribed for cardiovascular risk reduction but have been linked to a range of adverse effects. Tubulointerstitial nephritis (TIN), a potentially serious renal condition, has been sporadically reported with statin use.
Ayesha Yasmeen, Ayesha Yasmeen, Mamoon H. Syed, Mamoon H. Syed, Amani Khardali, Amani Khardali, Hadi A. Almansour, Hadi A. Almansour, Thamir M. Alshammari, Thamir M. Alshammari   +9 more
doaj   +1 more source

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