From a pyramid to an amphitheatre (triangle to circle): embracing the totality of evidence for the postmarketing evaluation of the safety of therapeutic interventions [PDF]
BMJ OpenObjectives To propose a novel approach to evidence-based medicine (EBM) for medication safety. To critically evaluate the appropriateness of the traditional pyramid hierarchy of evidence for pharmacovigilance.Key arguments For over three decades, the ...
Saad Shakir, Samantha Lane
doaj +2 more sources
Analysis of Global Drug Development Pathways and Postmarketing Safety in Japan: Local Studies May Reduce Drug‐Related Deaths [PDF]
Clinical and Translational Science, 2019 Recent International Conference on Harmonization (ICH) guidelines provide pharmaceutical companies with regulatory justifications to pursue various global drug‐development pathways, in some of which “local” dose‐ranging and/or pivotal phase III studies ...
Tomoko Kawamura Okubo, Shunsuke Ono
doaj +2 more sources
Postmarketing analysis of sotatercept: identifying serious unlabelled events [PDF]
Open HeartPurpose Sotatercept, an activin signalling inhibitor approved in March 2024 for pulmonary arterial hypertension (PAH), demonstrated efficacy in clinical trials.
Mei Zhang +4 more
doaj +2 more sources
Safety and effectiveness of apixaban in Japanese patients with nonvalvular atrial fibrillation in clinical practice: A regulatory postmarketing surveillance, the STANDARD study [PDF]
Journal of Arrhythmia, 2019 Background Apixaban, a non‐vitamin K oral anticoagulant (NOAC), was approved in Japan in 2012 for the prevention of thromboembolic events in patients with nonvalvular atrial fibrillation (NVAF).
Hiroshi Inoue +5 more
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Safety and Performance of Postmarketing Breast Implants: An Integrated Review with Technovigilance Data. [PDF]
J Clin MedRamalho AAL +8 more
europepmc +3 more sources
Postmarketing Research for Opioid Abuse-Deterrent Formulations: A Narrative Review [PDF]
Journal of Pain ResearchLynn Webster,1 Jeff Gudin,2 Jody L Green,3 Charles E Argoff4 1Dr. Vince Clinical Research, Overland Park, KS, USA; 2University of Miami, Miller School of Medicine, Miami, FL, USA; 3Inflexxion, a Division of Uprise Health, Irvine, CA, USA; 4Department of ...
Webster L, Gudin J, Green JL, Argoff CE
doaj +1 more source
An Open-Label, Multicentre, Observational, Post-Marketing Study to Monitor the Safety and Effectiveness of Umeclidinium/Vilanterol in Korean Patients [PDF]
Tuberculosis and Respiratory Diseases, 2023 Background Umeclidinium/vilanterol (UMEC/VI; ANORO ELLIPTA, GSK) is a commonly used dual bronchodilator. This study evaluated the safety and effectiveness of UMEC/VI in Korean patients with chronic obstructive pulmonary disease (COPD) over a 6-year ...
Eun-Yeong Cho +4 more
doaj +1 more source
Postmarketing surveillance studies. [PDF]
BMJ, 1992 Salhi Haji Abadi Ebrahim +3 more
openaire +3 more sources
Real-World Use of Generic Meropenem: Results of an Observational Study
Antibiotics, 2021 Background: To determine the therapeutic effect and tolerability of meropenem in routine clinical practice, in terms of clinical and microbiological response.
Santiago Garnica-Velandia +2 more
doaj +1 more source
Unanticipated Adverse Events With Tirzepatide: Three Cases Underscoring the Importance of Postmarketing Monitoring. [PDF]
JCEM Case RepColorado M +2 more
europepmc +3 more sources