Results 121 to 130 of about 235,421 (285)

Optimization of pharmaceutical research and development by early‐phase assessment of investigational medicinal products

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Small and mid‐sized pharmaceutical innovators often have limited in‐house health economics and market access expertise, and may struggle to align development strategies of investigational medicinal products with health system needs and payer expectations.
Zoltán Kaló   +5 more
wiley   +1 more source

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

open access: yesBritish 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   +3 more
wiley   +1 more source

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

open access: yesBritish 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   +4 more
wiley   +1 more source

Safety concerns reported by coroners following fentanyl patch fatalities in England, Wales and Northern Ireland between 1997 and 2024

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aim To identify safety concerns reported by coroners following fentanyl patch‐related deaths in England, Wales and Northern Ireland, and determine differences in coronial reporting. Methods A systematic case series linking the National Programme on Substance Use Mortality (NPSUM) and the Preventable Deaths Tracker (PDT) (https ...
Eman Mshari   +2 more
wiley   +1 more source

Cost‐effectiveness of DPYD genotyping prior to fluoropyrimidine‐based treatment for colorectal cancer in Wales

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Background Regulatory guidance in the United Kingdom advises DPYD genotyping prior to fluoropyrimidine‐based treatment. This economic evaluation estimated the costs and outcomes associated with DPYD screening prior to prescribing fluoropyrimidines for colorectal cancer in Wales and also considers additional variants to those included in ...
Catrin O. Plumpton   +8 more
wiley   +1 more source

Universal civil jurisdiction and reparation for international crimes

open access: yes, 2020
The author examines the attractive notion of universal civil jurisdiction and its possible use to ensure the reparation for international crimes.
beatrice bonafe
core  

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

open access: yesBritish 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   +8 more
wiley   +1 more source

Resolution of international environmental conflicts: sovereignty, international jurisdiction and ecological intervention
Resolução de conflitos ambientais internacionais: soberania, jurisdição internacional e ingerência ecológica

open access: yesScientia Iuris, 2008
International conflicts related to environment disrespect have begun recently. Among the forms to solve international environmental conflicts there is ecological intervention and international jurisdiction, which end up affecting the sovereignty ...
Eliane Moreira Lorenzet   +1 more
doaj  

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

open access: yesBritish 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   +10 more
wiley   +1 more source

Guantanamo Bay, Abandoned Being and the Constitution of Jurisdiction

open access: yes, 2006
Book synopsis: For much of the history of the western legal order, jurisdiction has been the first question of law. This book investigates the difference that jurisdiction continues to make to the ordering of normative existence.
Motha, Stewart
core  

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