Results 231 to 240 of about 3,001,017 (302)

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

Dissemination characteristics and influencing factors of topic circles in multi-layer public opinion dissemination. [PDF]

Front Public Health
Zhu X, Yu G, Zhang Y, Ma N.
europepmc   +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

Risk identification and assessment of Internet public opinion on public emergencies based on Bayesian network and association rule mining. [PDF]

Front Public Health
You M, Pan X, Zhu C.
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

Awakening, condensation, and sedimentation: the correlation mechanism between topics and emotions in online public opinion from the psychosocial anchoring perspective. [PDF]

Front Psychol
Yu H, Ma M, Yu X, Fang P.
europepmc   +1 more source

Empowering citizens to spontaneously report suspected adverse drug reaction: Systematic literature review of interventions and their impact

British Journal of Clinical Pharmacology, EarlyView.
This systematic literature review aimed to identify and characterize existing interventions designed to empower citizens to spontaneously report adverse drug reactions (ADRs) and to determine which interventions have been shown to be the most effective internationally. The research question was structured using the PICO framework.
Margarida Perdigão, Ana Margarida Advinha, Manuel José Lopes, Sofia de Oliveira Martins   +3 more
wiley   +1 more source

Public opinion on policy interventions for regulating four unhealthy commodity industries: a cross-sectional online survey of a representative sample of British adults 2023. [PDF]

BMC Public Health
Reed E, Buss V, Bebbington C, Bunce L, Cheeseman H, Severi K, Jenner K, Collin J.   +7 more
europepmc   +1 more source

The evolving therapeutic landscape of spinal muscular atrophy – A scoping review of investigational agents, emerging delivery technologies and strategic innovations

British Journal of Clinical Pharmacology, EarlyView.
Spinal muscular atrophy (SMA) is a severe neuromuscular disease with emerging therapeutic complexity. This review aims to systematically map the global pipeline of investigational treatments for SMA. Using ClinicalTrials.gov and complementary international registries, we identified 21 planned or ongoing interventional trials from 2020 to 2025 targeting
Andrej Belančić, Patrick Eustaquio, Elvira Meni Maria Gkrinia, Ivana Stević, Eugen Javor, Yun Wah Lam, Slobodan Janković, Dinko Vitezić   +7 more
wiley   +1 more source

Public opinion on civil war in the USA as of mid-2024: findings from a nationally representative survey. [PDF]

Inj Epidemiol
Wintemute GJ, Li Y, Wright MA, Crawford A, Tomsich EA.   +4 more
europepmc   +1 more source