Results 201 to 210 of about 2,438,268 (292)

Age‐related differences in hydroxychloroquine‐associated adverse events: A pharmacovigilance study based on the FDA Adverse Event Reporting System

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims This real‐world pharmacovigilance study utilizes FDA Adverse Event Reporting System (FAERS) data (2004–2024) to characterize age‐related disparities in hydroxychloroquine (HCQ)‐associated adverse events (AEs), addressing gaps in age‐stratified risk assessment. Methods Disproportionality analysis (reporting odds ratios, RORs) and parametric Weibull
Guanghan Sun   +4 more
wiley   +1 more source

Primary health care policy advocacy in Europe: A cross-sectional study of family medicine associations. [PDF]

open access: yesEur J Gen Pract
Gómez-Bravo R   +16 more
europepmc   +1 more source

Low‐intervention clinical trials in Spain: Do they progress?

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Low‐Intervention Clinical Trials (LICTs) are generally pragmatic trials that investigate medicinal products already authorized for use. In 2014, simplified regulatory frameworks were introduced for LICTs with the aim of reducing regulatory burden and operational complexity, to foster non‐commercial clinical trials (NCCTs); the mandatory ...
Claudia Erika Delgado‐Espinoza   +4 more
wiley   +1 more source

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola   +5 more
wiley   +1 more source

Safety concerns reported by coroners following fentanyl patch fatalities in England, Wales and Northern Ireland between 1997 and 2024

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
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

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