Results 151 to 160 of about 6,866 (219)
British Journal of Clinical Pharmacology, EarlyView.Introduction In recent years, the treatment of spinal muscular atrophy (SMA), a rare disease, has significantly progressed, improving patients' survival and overall quality of life. However, current SMA treatments are expensive, and some (nusinersen) are very inconvenient for patients.
Andrej Belančić +4 more
wiley +1 more source
How the HTAR will contribute to a value‐based decision‐making for medicinal products across the EU
British 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
British 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?
British 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
British 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
Evaluating a virtual paediatric adverse drug reaction clinic
British Journal of Clinical Pharmacology, EarlyView.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
British Educational Research Journal, EarlyView.Abstract Employability remains a critical issue for international students in the United Kingdom. This study adopts the Employability Agency Framework proposed by Pham et al. to explore how a group of international students actively exercised their agency to enhance their employability during their Master's studies in the United Kingdom.
Hoang Nguyen, Ming Cheng
wiley +1 more source
Understanding exam access arrangements in practice: Challenges and opportunities
British Educational Research Journal, EarlyView.Abstract Secondary students with specific learning difficulties (SpLD) often face challenges with academic tasks, particularly with high‐stakes examinations. Exam access arrangements (EAA) are provided as reasonable adjustments to reduce disadvantage for students with SpLD.
Catherine Antalek +2 more
wiley +1 more source
What works in internal alternative provision? A salutogenic analysis
British Educational Research Journal, EarlyView.Abstract Schools across England are setting up ‘internal alternative provision’ to meet the social, emotional and mental health needs of increasing numbers of pupils at risk of suspension, exclusion and absence. However, there is little guidance about what good practice looks like.
Emma Simpson
wiley +1 more source