Results 111 to 120 of about 77,040 (258)

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

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, Miriam G. Mooij, Matthijs de Hoog, Saskia N. de Wildt   +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, Milutin Kostic, Barbara Mintzes, Gianna D'Ambrozio, Allen Shaughnessy   +4 more
wiley   +1 more source

Effects of NOS inhibitors and a NO precursor on the expression of tolerance to diazepam-induced motor impairment in mice

Current Issues in Pharmacy and Medical Sciences
The effect of nonselective NOS inhibitors: NG-nitro-L-arginine (L-NOARG) and NG-nitro-L-arginine methyl ester (L-NAME) and a NO precursor, L-arginine on the expression of tolerance to the diazepam (DZ)-induced motor impairment was investigated in this ...
Jolanta Orzelska, Sylwia Talarek, Joanna Listos, Sylwia Fidecka   +3 more
doaj  

From anthelmintic to neuro‐oncology: A systematic review of mebendazole repurposing for brain tumour therapy

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Mebendazole (MBZ), a benzimidazole anthelmintic with established clinical use, has emerged as a repurposing candidate for primary brain tumours due to its multimodal anticancer actions and central nervous system penetrance. This systematic review synthesizes preclinical and clinical evidence evaluating MBZ's efficacy, mechanisms of action ...
Ciara B. Blum, Milli McMenamin, Tessa Khoo, John M. Edwin, Prathibha Jose, Liam A. O’Callaghan   +5 more
wiley   +1 more source

Repeated intradermal lipopolysaccharide challenge responses in healthy volunteers: Implications for clinical pharmacology studies

British Journal of Clinical Pharmacology, EarlyView.
Aim Intradermal application of lipopolysaccharide (LPS), a Toll‐like receptor 4 agonist, induces a local inflammatory response and is used as a human challenge model to evaluate the pharmacodynamics of investigational medicinal products. While currently applied in a single, parallel‐group setting, alternative within‐subject designs involving repeated ...
Alexandra A. J. Sillé, Juliette A. van den Noort, Iva Lelios, Diana R. Pereira, Marzia A. Scelsi, Erica S. Klaassen, Philipp Schoenenberger, Naomi B. Klarenbeek, Pierre‐Eric Juif, Pascal Espie, Manon A. A. Jansen, Matthijs Moerland, Richard W. D. Welford   +12 more
wiley   +1 more source

Precision medicine in paediatrics: Progress and priorities

British Journal of Clinical Pharmacology, EarlyView.
Precision medicine is revolutionizing personalized healthcare, advancing both diagnostics and therapeutics at an unprecedented pace. Reviewing the paediatric applications of pharmacometrics, pharmacogenomics and advanced therapy medicinal products highlights not only the relevance of these exciting innovations to frontline care but also the significant
Nicola Husain, Claire Booth, Joseph F. Standing, Charlotte I. S. Barker   +3 more
wiley   +1 more source

Author Correction: Pharmacological markers of HIV prevention for oral pre-exposure prophylaxis in men who have sex with men. [PDF]

Nat Commun
Iannuzzi S, Müller M, Yu Y, Zhang L, Hendrix CW, Bies RR, von Kleist M.   +6 more
europepmc   +1 more source

A phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF‐07261271 in healthy participants

British Journal of Clinical Pharmacology, EarlyView.
Aim There is an unmet need for more effective therapies in inflammatory bowel disease (IBD). A single drug that blocks multiple distinct pathogenic pathways may offer therapeutic benefit superior to current monotherapies. PF‐07261271, a bispecific antibody targeting both the p40 subunit of interleukin‐12/23 and tumour necrosis factor‐like cytokine 1A ...
Srividya Neelakantan, Christopher Banfield, Kenneth Hung, Anna Sapone, Vivek Pradhan, Yuxi Zhao, Dana Parsons‐Rich, Grace Lee, Bryce G. Johnson, Elena Peeva, Michael S. Vincent, Valerie M. Clerin   +11 more
wiley   +1 more source

Reply to: "Promising Drugs Require Proper Testing": Let's Not Confuse Pharmacodynamics With Clinical Efficacy. [PDF]

Clin Transl Sci
Ben Ghezala I, Bardou M.
europepmc   +1 more source

Supratherapeutic drug concentration triggers: A novel data‐driven approach to assess their value for medication safety surveillance in intensive care

British Journal of Clinical Pharmacology, EarlyView.
Aims Electronic triggers (e‐triggers) are used as screening signals to detect potential adverse drug events (ADEs) and offer an effective system level approach for medication safety surveillance. Their clinical utility is typically evaluated through time‐consuming manual chart review by experts, limiting implementation.
Anne Paulien Langermans, Izak A. R. Yasrebi‐de Kom, Dylan Wayne de Lange, Nicolette Fransisca de Keizer, Joanna E. Klopotowska, on behalf of the RESCUE Study group, C. S. C. Bouman, E. N. van Roon, P. F. Schutte, J. ten Cate, D. van Balen, S. Hendriks, C. Lau, W. J. Vermeijden, A. Beishuizen, J. B. Masselink, P. E. Spronk, H. J. M. van Kan, P. W. de Feiter, E. J. Wils, A. Wieringa, A. J. Valkenburg, W. M. van den Bergh, M. H. Renes, W. Bult, E. de Jonge, M. Hoeksema, E. J. Wesselink, I. M. Purmer, B. E. Bosma, S. H. W. van Bree, H. J. W. Lammers, R. J. Bosman, E. J. F. Franssen, A. Karakus, M. Sigtermans, E. M. Kuck, D. A. Dongelmans, M. J. H. Aries, E. V. Uijtendaal, M. C. Reuland   +40 more
wiley   +1 more source