Results 101 to 110 of about 17,075 (245)

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

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola, Aleksandar Gigov, Hubertus G. M. Leufkens, Andrew Bate, Marie Louise De Bruin, Helga Gardarsdottir   +5 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

The Geneva initiative on psychiatry

European Psychiatry, 1998
openaire   +1 more source

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

British 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, Christine Leopold, Joyce M. Hoek, Raymond M. Schiffelers, Marie L. De Bruin   +4 more
wiley   +1 more source

Exploring new avenues: Psychedelic‐assisted therapy for young people

British Journal of Clinical Pharmacology, EarlyView.
Rates of mental illness in young people are increasing, whereas the development of novel mental health treatments has not significantly progressed. Psychedelic‐assisted therapy, using substances such as psilocybin and 3,4‐methylenedioxymethamphetamine (MDMA), has shown potential in the treatment of mental illnesses in the adult population, including ...
Ioanna Artemis Vamvakopoulou, Dasha Nicholls, David J. Nutt, Martina Di Simplicio   +3 more
wiley   +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

Characteristics and temporal trends of EU teratological safety signals and information dissemination to healthcare professionals in the Netherlands—A contribution of the ConcePTION project

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Although regulatory responses to safety signals have been studied, pregnancy‐specific data and their dissemination to medical professionals remain unclear. This study examined the characteristics and temporal trends of teratological safety signals prompting the European Medicines Agency to implement risk minimization measures.
Yrea R. J. van Rijt‐Weetink, Rosanne E. Huisman, Jan‐Peter van Wieringen, H. J. M. J. (Ineke) Crijns, Florence P. A. M. van Hunsel, Anneke L. M. Passier, Sander Borgsteede, A. C. G. (Toine) Egberts, Laura M. Yates, Eugène P. van Puijenbroek   +9 more
wiley   +1 more source

UGT1A1 genotype testing for irinotecan: A guideline developed by the UK Centre of Excellence in Regulatory Science and Innovation in Pharmacogenomics (CERSI‐PGx)

British Journal of Clinical Pharmacology, EarlyView.
Abstract Irinotecan, a topoisomerase I inhibitor, is available as both non‐pegylated and pegylated formulations. The non‐pegylated formulation is licensed for use in advanced colorectal cancer either in combination with other agents or as monotherapy.
Dharmisha Chauhan, Cinzia Dello Russo, Jack Thompson, Dyfrig A. Hughes, Katherine Payne, Maria Tsakiroglou, Paul Ross, Rena Chauhan, Simon Jenkinson, Jessica Keen, Sophie Harding, Eleanor Lau, Michael Braun, Roshan Agarwal, Richard Adams, Elisabeth Rolf, Farah Al‐Sheikhli, Sarah Mitchell, Ruth Hammond, Rosie Roberts, Lorna Cairns, Shirley Heggarty, Janet Graham, Justin Mencel, Munir Pirmohamed   +24 more
wiley   +1 more source

Embracing novel thinking to safeguard against airborne pathogens in indoor spaces

IJTLD Open
H. van der Westhuizen, J.-A. Nice, C. Tudor, Y. Liu, S. Ahmedov, A.R. Kansal, P.A. Jensen, R.L. Vincent, G. Mustapha, V. Vauhkonen, I.M. Ochoa Delgado, M. van der Walt, G. Volchenkov   +12 more
doaj   +1 more source