Results 181 to 190 of about 1,577,570 (335)

Low‐intervention clinical trials in Spain: Do they progress?

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Low‐Intervention Clinical Trials (LICTs) are generally pragmatic trials that investigate medicinal products already authorized for use. In 2014, simplified regulatory frameworks were introduced for LICTs with the aim of reducing regulatory burden and operational complexity, to foster non‐commercial clinical trials (NCCTs); the mandatory ...
Claudia Erika Delgado‐Espinoza, Mayro J. Cortés Pestana, Kristopher Amaro, Rosa M. Antonijoan, Caridad Pontes   +4 more
wiley   +1 more source

Clinical pharmacology and prescribing education: An updated medical school curriculum from the British Pharmacological Society

British Journal of Clinical Pharmacology, EarlyView.
Aims Prescribing is a complex, essential skill that doctors must acquire to practice medicine safely and effectively. The British Pharmacological Society has historically provided a core curriculum to guide clinical pharmacology and prescribing education in UK medical schools.
Dagan O. Lonsdale, Clare Guilding, Jennifer Koenig, Michael Okorie, Reecha Sofat, Simon Maxwell   +5 more
wiley   +1 more source

Pragmatism in clinical trials: essential, not optional

European Heart Journal, 2022
Muhammad Shariq Usman, Javed Butler, Muhammad Shahzeb Khan   +2 more
openaire   +2 more sources

Population pharmacokinetic modelling of amoxicillin in human breast milk—A contribution from the ConcePTION project

British Journal of Clinical Pharmacology, EarlyView.
Aims Amoxicillin, a widely used β‐lactam antibiotic, requires improved pharmacokinetic characterization during breastfeeding. This study used a population pharmacokinetic (PopPK) approach to model amoxicillin concentrations in breast milk, identify variability sources and estimate infant exposure, applying worst‐case scenarios.
Sarah Baklouti, Virginie Rigourd, Alice Panchaud, Hedvig Nordeng, Karel Allegaert, Pieter Annaert, Miao‐Chan Huang, Anaelle Monfort, Monia Guidi, Peggy Gandia   +9 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

Clinical endpoints in pragmatic heart failure trials: From data collection to clinical endpoint classification

ESC Heart Failure
Clinical endpoint classification (CEC)—that is, evaluation of clinical events using pre‐defined criteria—is commonly conducted in clinical trial operations to ensure systematic and consistent assessment of endpoints needed to assess the intervention's ...
Veraprapas Kittipibul, Harriette G.C. Van Spall, William Schuyler Jones, Marat Fudim, Robert J. Mentz, Kevin Anstrom, Bertram Pitt, Patrice Desvigne‐Nickens, Jerome L. Fleg, Camilla Hage, Stefan James, Claes Held, Lars Lund, Adam DeVore   +13 more
doaj   +1 more source

Clinical Trials With Pragmatic Elements

Clinical Pharmacology and Therapeutics
Clinical trials with pragmatic elements can capture diverse patient populations, enable efficient follow-up, and reflect routine clinical practices; yet there is limited understanding of their design features, characteristics, and use of real-world data (RWD). Based on a targeted search of PubMed/EMBASE (Jan-2016 to Jul-2024), a review was conducted to
Su, Le, Chen, Lei, Betigeri, Seema, Dreyer, Nancy, Gardarsdottir, Helga, Hendricks-Sturrup, Rachele, Burcu, Mehmet   +6 more
openaire   +1 more source

The decline of 6‐thioguanine nucleotides is not linked to impaired efficacy or safety of thiopurines in pregnant women with inflammatory bowel disease

British Journal of Clinical Pharmacology, EarlyView.
Background Thiopurines are used to maintain remission in inflammatory bowel disease (IBD). These drugs are metabolized into 6‐thioguanine nucleotides (6‐TGN), associated with efficacy, and 6‐methylmercaptopurine ribonucleotides (6‐MMPR), associated with adverse drug reactions. Pregnancy has been linked to a shift in thiopurine metabolism, characterized
Dianne G. Bouwknegt, Paola Mian, Femke Groen, Denise van den Berg‐Zuiddam, Andrea E. van der Meulen, Femke Crouwel, Nanne K. de Boer, Debbie S. Deben, Dennis R. Wong, Luc J. J. Derijks, Gerard Dijkstra, Arno R. Bourgonje, C. Janneke van der Woude, Marijn C. Visschedijk   +13 more
wiley   +1 more source

A pipeline crisis or a sustainability crisis? Local and national succession planning for headteachers in England

British Educational Research Journal, EarlyView.
Abstract Recruiting and retaining school leaders is a challenge in many systems worldwide. Previous research has identified three distinct ways in which succession planning can be conceptualised and approached: a ‘pipeline’ approach seeks to match supply and demand for the posts that need filling; a ‘pool’ strategy involves proactively identifying and ...
Toby Greany, Pat Thomson, Tom Perry, Mike Collins   +3 more
wiley   +1 more source

Potential for use of Al/machine learning for pharmacovigilance: Is there a role for regulators?

British Journal of Clinical Pharmacology, EarlyView.
Christina Gao, Ashley M. Hopkins, Andrew Rowland, Stephen Bacchi   +3 more
wiley   +1 more source