Results 181 to 190 of about 119,278 (250)

Switching disease‐modifying therapies in patients with spinal muscular atrophy: A systematic review on effectiveness outcomes

British Journal of Clinical Pharmacology, EarlyView.
With multiple disease‐modifying therapies now available, treatment switching has become an important clinical consideration in the management of spinal muscular atrophy (SMA). While some switches are prompted by suboptimal clinical response, more commonly they are driven by treatment burden, convenience, or adverse events.
Andrej Belančić, Elvira Meni Maria Gkrinia, Patrick Eustaquio, Andrea Katrin Faour, Dinko Vitezić   +4 more
wiley   +1 more source

Pentoxifylline dose finding trial in preterm neonates with suspected late onset sepsis (PTX‐trial)

British Journal of Clinical Pharmacology, EarlyView.
Aim The aim of this study (PTX‐trial) is to determine the optimal dose of pentoxifylline (PTX) in preterm neonates (gestational age < 30 weeks) with (suspected) late onset sepsis (LONS). Methods The PTX‐trial is a prospective multicentre open‐label sequential dose‐optimization study with an adapted continual reassessment method.
Serife Kurul, H. Rob Taal, Jan Mazela, Ryszard Lauterbach, Irwin K. M. Reiss, Karel Allegaert, Robert B. Flint, Sinno H. P. Simons   +7 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

Do drugs approved via expedited approval pathways have therapeutic advantages? A systematic review and meta‐analysis

British Journal of Clinical Pharmacology, EarlyView.
Regulators use expedited approval pathways to speed market approval and patient access to promising new drugs. However, there is uncertainty about whether these pathways are successful in approving drugs with significant therapeutic advantages. This systematic review aims to examine the safety, effectiveness and cost‐effectiveness of drugs approved via
Ashleigh Hooimeyer, Eliza J. McEwin, Zhicheng Wang, Joel Lexchin, Barbara Mintzes   +4 more
wiley   +1 more source

Pharmacokinetics and safety of tezepelumab in children with mild, moderate or severe asthma and adolescents with mild‐to‐moderate asthma

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Tezepelumab is a human monoclonal antibody that blocks the activity of thymic stromal lymphopoietin and is approved for adolescents and adults with severe asthma. This analysis assessed pharmacokinetics (PK), pharmacodynamics and safety of tezepelumab up to 85 days postdose in adolescents and children.
Anna Lundahl, Jonathan Grigg, Lubna Abuqayyas, Piotr Kuna, Gillian Hunter, Beata Pawlikowska, Jacob Leander, Michael Levin, Atul Gupta, James Paton, Katharine C. Pike, Jane R. Parnes, Gun Almqvist, Stephanie L. Roseti, on behalf of the study investigators   +14 more
wiley   +1 more source

The effect of mild and moderate hepatic impairment on the pharmacokinetics, safety and tolerability of balcinrenone

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Balcinrenone (previously AZD9977) is a novel selective non‐steroidal mineralocorticoid receptor antagonist (MRA) with a differential mechanism of action relative to approved MRAs. The aim of this trial was to assess the pharmacokinetics, safety and tolerability of balcinrenone in participants with mild and moderate hepatic impairment ...
Anna L. Eriksson, Deeyen Karsanji, Bonifride Tuyishimire, Joanna Parkinson, Maria Heijer, Tadeusz Pawlik, Judith Hartleib‐Geschwindner, Maria Leonsson‐Zachrisson, Hans Ericsson   +8 more
wiley   +1 more source

Cardiovascular and neuropsychiatric outcomes with PCSK9 inhibitors in atherosclerotic cardiovascular disease: A retrospective cohort study

British Journal of Clinical Pharmacology, EarlyView.
Study design and main findings. After 1:1 propensity score matching, 60 885 PCSK9 inhibitor users and 60 885 statin‐only users with ASCVD were compared. Kaplan–Meier curves show 12‐month cumulative event‐free survival for MACE, psychiatric disease, and neurodegenerative disease.
Tianshu Gu, Yang Chen, Nan Zhang, Uazman Alam, Riccardo Proietti, Tong Liu, Kang‐Yin Chen, Gregory Y. H. Lip   +7 more
wiley   +1 more source

Regulatory harmonization: Evolution, globalization and future directions

British Journal of Clinical Pharmacology, EarlyView.
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm, Elaine Y. L. Blair, Christine Y. Lu   +2 more
wiley   +1 more source

Efficacy and safety of cannabinoids in the treatment of spasticity in multiple sclerosis: A systematic review of randomized clinical trials

British Journal of Clinical Pharmacology, EarlyView.
Aims This work aimed to evaluate the efficacy and safety of cannabinoids for the treatment of MS‐related spasticity. Methods Systematic searches were conducted in PubMed, EMBASE, and LILACS on 2 December 2025. Randomized controlled trials evaluating natural or synthetic cannabinoids for MS‐related spasticity were included.
Letícia Hamm‐Buiar, Daniela Gorski, Marcela Harumi Kagueiama, Astrid Wiens   +3 more
wiley   +1 more source

Migrant success in UK Education: Are there lessons for government social mobility policy?

British Educational Research Journal, EarlyView.
Abstract The school achievement and career aspirations of 23 sixth form students at a multi‐cultural urban academy in the UK are explored through interviews. The sample includes 16 s‐generation migrants, 6 UK‐born students with migrant parents and 1 UK‐born student, selected to represent a cohort of over 300 post‐16 learners.
Bernard Barker, Kate Hoskins
wiley   +1 more source