Results 201 to 210 of about 95,061 (269)

Banning loot boxes for minors: A public health framework and the case of Brazil. [PDF]

J Behav Addict
Spritzer DT, Fortim I, Roza TH, Kessler FHP, Kim HS.   +4 more
europepmc   +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

The long-term impact of Spain's 2010 Anti-Smoking Law: A counterfactual and prospective time-series analysis. [PDF]

AIMS Public Health
Martín-Álvarez JM, Galiano A, Hoz BV, Lyalkov S.   +3 more
europepmc   +1 more source

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

Prospect of Fiduciary Duty as a Mitigating Factor for Healthcare Expenses. [PDF]

J Law Med Ethics
Muir D.
europepmc   +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

Building Institutional Legitimacy: Elites, Markets, and Inequality Through the Voice-Choice-Transparency-Trust (VCTT) Framework. [PDF]

F1000Res
Malliaros P, Alejandro Pacheco-Jaramillo W.   +1 more
europepmc   +1 more source

A phase 1 evaluation of inhaled oxytocin: Physiologically‐based pharmacokinetic model informed dosing of a novel heat‐stable oxytocin delivery system

British Journal of Clinical Pharmacology, EarlyView.
Aim To develop and validate a physiologically‐based pharmacokinetic (PBPK) model enabling inhaled oxytocin dose selection for clinical evaluation. Subsequently, to conduct a phase 1 study investigating the pharmacokinetics and safety of selected doses of an optimized inhaled oxytocin product in healthy, non‐pregnant female participants.
Pete Lambert, Carl M. J. Kirkpatrick, Rory Marriott, Siladitya Ray Chaudhuri, David Polidori, Bart Remmerie, Michelle P. McIntosh   +6 more
wiley   +1 more source

Regulation of the veterinary profession: the authorization to practice, origins, milestones, and emerging challenges. [PDF]

Front Vet Sci
Vaarten J, De Briyne N, van Herten J, De Vliegher S.   +3 more
europepmc   +1 more source