Results 171 to 180 of about 77,176 (263)
Abstract Despite regulatory progress being made in the past two decades, off‐label drug use in paediatrics remains pervasive, with prevalence estimated between 3% and 97% of prescriptions across different clinical settings. Off‐label use—defined as prescribing outside the conditions described in the Summary of Product Characteristics (SmPC)—is often ...
Tjitske M. van der Zanden +3 more
wiley +1 more source
How green are large language models for radiology report labelling? Comparing human, rule-based and hybrid workflows. [PDF]
Fink MA +10 more
europepmc +1 more source
Zuranolone: A case study in (regulatory) rush to judgement?
Abstract Sage, in collaboration with Biogen, submitted a new drug approval for zuranolone for postpartum depression (PPD) and major depressive disorder (MDD) in December 2022. In August 2023, the US Food and Drug Administration granted approval for PPD but denied approval for MDD.
Lisa Cosgrove +4 more
wiley +1 more source
A Pragmatic Bayesian Adaptive Trial Design Based on the Value of Information: The Value-Driven Adaptive Design. [PDF]
Dymock M +5 more
europepmc +1 more source
Abstract Aim To identify safety concerns reported by coroners following fentanyl patch‐related deaths in England, Wales and Northern Ireland, and determine differences in coronial reporting. Methods A systematic case series linking the National Programme on Substance Use Mortality (NPSUM) and the Preventable Deaths Tracker (PDT) (https ...
Eman Mshari +2 more
wiley +1 more source
The Economic Costs of Congenital Hearing Loss in a South African Cohort. [PDF]
Tombe-Mdewa W +5 more
europepmc +1 more source
Evaluating a virtual paediatric adverse drug reaction clinic
Aims Adverse drug reactions (ADRs) are a common problem in paediatric health care. There is limited access to expertise in the evaluation and management of potential ADRs in children, limiting access to these services and creating delays in assessment and management.
Emily Hauck +2 more
wiley +1 more source
Economic evaluation of stapokibart for chronic rhinosinusitis with nasal polyps in China: a cost-effectiveness analysis. [PDF]
Yang J, Ren L, Xie F, Shao R, Jiang R.
europepmc +1 more source
Aims The Black Triangle Scheme, introduced in 2018 in Australia, does not appear to have increased the quantity of adverse drug event (ADE) reports. This study evaluated healthcare professionals' (HCPs') and consumers' awareness of the scheme, its influence on intentions for future ADE reporting, and suggested improvements.
Eyob Alemayehu Gebreyohannes +7 more
wiley +1 more source

