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
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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
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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
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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
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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
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Time Series Analysis of the Effectiveness and Safety of Capsule Endoscopy between the Premarketing and Postmarketing Settings: A Meta-Analysis. [PDF]
PLoS ONE, 2016 BACKGROUND:Clinical studies for assessing the effectiveness and safety in a premarketing setting are conducted under time and cost constraints. In recent years, postmarketing data analysis has been given more attention.
Kazuo Iijima +2 more
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Epilepsia Open, 2022 Objective To assess retention, dosing, efficacy, and safety of perampanel in a large cohort of patients with epilepsy during routine clinical care. Methods PROVE was a retrospective, non‐interventional Phase IV study (NCT03208660).
Robert T. Wechsler +10 more
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BMJ Open, 2023 Objective We aimed to provide insight into differences in drug review decisions made by the US Food and Drug Administration’s (FDA) accelerated approval (AA) pathway and the European Medicines Agency’s (EMA) conditional marketing authorisation (CMA ...
Yi Chen +8 more
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Safety of oral nemonoxacin: A systematic review of clinical trials and postmarketing surveillance
Frontiers in Pharmacology, 2022 Background: Postmarketing safety analysis is an effective supplement for new drugs in clinical practice. Therefore, we aimed to systematically assess the safety of oral nemonoxacin malate, the first approved C-8-methoxy non-fluorinated quinolone, in ...
Jinyi Yuan +5 more
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Frontiers in Medicine, 2023 The Pharmaceuticals and Medical Devices Agency (PMDA) has conducted many pharmacoepidemiological studies for postmarketing drug safety assessments based on real-world data from medical information databases.
Haruka Shida +10 more
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