Results 231 to 240 of about 9,746 (299)

Beyond the label: Rethinking off‐label drug use in paediatrics. Towards a scientifically grounded and safer future for paediatric pharmacotherapy

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
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

Zuranolone: A case study in (regulatory) rush to judgement?

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
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

Psychotropic medication use among community dwellers with and without Parkinson's disease – A nationwide cohort study

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aims We studied the prevalence of psychotropic use and psychotropic polypharmacy in persons with Parkinson's disease (PD) during a 10‐year follow‐up, because longitudinal studies on this topic are scarce although non‐motor symptoms of PD are often treated with psychotropics.
Noora Nieminen   +4 more
wiley   +1 more source

Decoding RNA regulation: Challenges and opportunities for RNA‐based therapies in Europe

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract RNA‐based medicinal products represent a promising frontier in personalised medicine, offering sequence‐specific disease targeting at various molecular levels, yet their clinical translation in the European Union (EU) may be hindered by regulatory uncertainty around definitions and evidence requirements; this study therefore aims to identify ...
Olivia C. Lewis   +4 more
wiley   +1 more source

Development and partial validation of an RT-qPCR assay for the rapid detection of spring viremia of carp virus (SVCV). [PDF]

open access: yesFront Microbiol
Zhu P   +11 more
europepmc   +1 more source

Risk of venous thromboembolism after SARS‐CoV‐2 vaccination—Evidence from genome‐wide association study and population‐based observational study

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim We aimed to investigate whether genetic variation is associated with venous thromboembolism after immunization with SARS‐CoV‐2 vaccines. Methods We conducted a genome‐wide association study (GWAS) on cases of venous thromboembolism within 42 days after SARS‐CoV‐2 vaccination, recruited from reports of adverse drug reactions sent to the Swedish ...
Sofia Attelind   +7 more
wiley   +1 more source

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