Understanding Postmarketing Requirements and Commitments for CYP3A‐Mediated Drug–Drug Interactions: An Analysis of FDA‐Approved Drugs From 2015 to 2024 [PDF]
Clinical and Translational ScienceAddressing knowledge gaps at drug approval through drug–drug interaction (DDI)‐related postmarketing requirements (PMRs) and commitments (PMCs) is essential for safe and effective use.
Jingjing Yu +4 more
doaj +3 more sources
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
Effectiveness of drug postmarketing all-case surveillance as a safety measure in Japan
Therapeutic Advances in Drug Safety, 2021 Introduction: The drug pharmacovigilance system in Japan is similar to those in the European Union (EU) and the United States. As a unique Japanese pharmacovigilance program, postmarketing all-case surveillance (PMACS) is required. PMACS plays a key role
Ken Masamune, Hideyuki Kondo
exaly +2 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
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Characteristics and follow‐up of postmarketing studies of conditionally authorized medicines in the EU [PDF]
British Journal of Clinical Pharmacology, 2016 Marie Louise de Bruin, Jarno Hoekman
exaly +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 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
doaj +1 more source
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
doaj +1 more source
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
doaj +1 more source
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
doaj +1 more source