Results 81 to 90 of about 14,467 (210)

Standardization of measurement and reporting of medication adherence using the TEN‐SPIDERS tool for claims data

British Journal of Clinical Pharmacology, EarlyView.
This study provides the first open‐source tool to implement the complete TEN‐SPIDERS framework in linked datasets for the determination of the PDC for medication adherence. The TEN‐SPIDERS tool enables transparent, reproducible medication adherence research through automated reporting of all calculation parameters and flexible customization options ...
Adam C. Livori, Tzu‐Yung Kuo, Jenni Ilomäki, Monique F. Kilkenny, Stella Talic, Zanfina Ademi, J. Simon Bell, Jedidiah I. Morton, Lachlan L. Dalli   +8 more
wiley   +1 more source

Reflections on the origins and development of administrative and jurisdictional guarantees in France and Spain

Ars Iuris Salmanticensis, 2019
In the present work, we examine the origins of administrative guarantees, going back to France in the 18th century, and their counterpart in the Spanish legal order of the 19th century.
Enrique RIVERO YSERN
doaj  

Trends in publicly subsidized and private access to GLP‐1 medicines indicated for type 2 diabetes in Australia, 2020–2025

British Journal of Clinical Pharmacology, EarlyView.
Aims GLP‐1 medicines provide substantial cardio‐renal benefits for type 2 diabetes (T2D) and are increasingly used for weight loss. Most high‐income countries subsidize access for T2D with restrictions; use outside of these restrictions occurs through private prescriptions. Despite strong consumer demand, the extent of private access to GLP‐1 medicines
Michael O. Falster, Juliana de Oliveira Costa, Tamara Y. Milder, Joanne Carson, Cade Shadbolt, Brendon L. Neuen, Clare Arnott, Andrew Wilson, Min Jun, Nicole Pratt, Sallie‐Anne Pearson   +10 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

Medicines, misinformation and machines: Navigating infodemics in the generative AI era

British Journal of Clinical Pharmacology, EarlyView.
Health information is now widely accessed through smartphones, online searches and increasingly through generative artificial intelligence (AI). These systems create new opportunities for communication, and in some routine contexts, well‐governed AI assistants could reduce exposure to lower quality sources by providing cautious, evidence‐aligned ...
Natansh D. Modi, Lisa M. Kalisch Ellett, Michael D. Wiese, Ashley M. Hopkins   +3 more
wiley   +1 more source

Economic evaluations of antiobesity medications: A systematic literature review

British Journal of Clinical Pharmacology, EarlyView.
The global prevalence of obesity is rising rapidly. With several antiobesity medications approved and many more in development, understanding their economic value is increasingly important. This study reviews full economic evaluations of approved antiobesity medications to assess cost‐effectiveness and inform reimbursement and access decisions.
Martina Jurković, Almir Fajkić, Andrea Katrin Faour, Mirna Momčilović, Petra Turčić, Andrej Belančić   +5 more
wiley   +1 more source

Operationalization of the African Medicines Agency: Retrospective evaluation of the continental centralized pilot procedure timelines to recommendation and national registrations

British Journal of Clinical Pharmacology, EarlyView.
Aims Regulatory inconsistency across Africa causes duplicative assessments, prolonged approvals, and delayed medical access. To inform the African Medicines Agency (AMA), the African Medicines Regulatory Harmonisation (AMRH) piloted Africa's first continental scientific evaluation of human medicinal products.
Alex Juma Ismail, Lerato Moeti, Delese Mimi Darko, Stuart Walker, Sam Salek   +4 more
wiley   +1 more source

Toward the harmonization of bioequivalence guidelines in Europe: Commentary on the state of the art and future priorities under ICH M13A for immediate‐release oral forms

British Journal of Clinical Pharmacology, EarlyView.
Domenico Nocera, Giusi Forastiero, Andrea Logreco, Alessia Proietti, Antonio Galluccio, Carlotta Lunghi, Elisabetta Poluzzi, Fabrizio De Ponti   +7 more
wiley   +1 more source

Analysis of regulatory review models and approval timelines across selected African medicines regulatory authorities using the OpERA framework (2020–2024)

British Journal of Clinical Pharmacology, EarlyView.
Background The World Health Organization (WHO) developed the Global Benchmarking Tool (GBT) to assess national regulatory systems and support regulatory‐system strengthening across regulatory functions. Several African National Medicines Regulatory Authorities (NMRAs) have achieved Maturity Level 3 (ML3).
Constance Sakala Chisha, Stephanie Leigh, Makomani Siyanga, Grace Matimba, Richard Rukwata, Mercy Owusu‐Asante, Kwabena Frimpong‐Manso Opuni, Pratibha Sobrun, Boitumelo Semete‐Makokotlela, Adem Kermad, Stuart Walker   +10 more
wiley   +1 more source

Triangulation of dispensing and wastewater data for surveillance during lisdexamfetamine shortages: A descriptive time series analysis

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Lisdexamfetamine, a long‐acting stimulant for attention‐deficit hyperactivity disorder (ADHD), has experienced widespread shortages in Australia since late 2023, raising concerns about treatment continuity and shifts in stimulant use patterns.
Jack Janetzki, Emma Keller, Nicole Pratt, Cobus Gerber, Lisa Kalisch Ellett   +4 more
wiley   +1 more source