Results 151 to 160 of about 70,691 (256)

How the HTAR will contribute to a value‐based decision‐making for medicinal products across the EU

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
The European Union Health Technology Regulation 2021/2282 (HTAR) introduces joint assessment of health technologies (including medicinal products and medical devices) across EU Member States. It was signed into law in 2021 and came into full force in January 2025.
Roisin Adams, Michal Stanak
wiley   +1 more source

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

Barriers to Childhood Immunisation in Selected Zero-Dose Communities in Gauteng Province: A Qualitative Study. [PDF]

open access: yesVaccines (Basel)
Majola TN   +10 more
europepmc   +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

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

Unveiling healthcare disparities in Somalia: the hidden struggles of nomadic communities. [PDF]

open access: yesInt J Equity Health
Duale HA   +5 more
europepmc   +1 more source

HLA genotype testing for carbamazepine, oxcarbazepine and eslicarbazepine: A guideline developed by the UK Centre of Excellence in Regulatory Science and Innovation in Pharmacogenomics (CERSI‐PGx)

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Carbamazepine is licensed in the United Kingdom for the treatment of epilepsy, bipolar disorder and trigeminal neuralgia. The related compounds oxcarbazepine and eslicarbazepine are licensed for the treatment of epilepsy. These drugs can cause immune‐mediated hypersensitivity reactions, which typically affect the skin, and can be of variable severity ...
Lucy Galloway   +24 more
wiley   +1 more source

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