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
Abstract Background and Purpose Drug–drug interactions (DDIs) are associated with an increased risk of adverse drug reactions (ADRs). Hospitalized children are particularly vulnerable to DDIs and ADRs due to polypharmacy, frequent use of unlicensed or off‐label medications, and dosing regimens often extrapolated from adult data.
Emilie Laval +6 more
wiley +1 more source
A dual-stream deep learning framework for continuous sign language recognition to enhance communication accessibility in the Ha'il region. [PDF]
Harrouch H +3 more
europepmc +1 more source
Aims Ginisortamab, a first‐in‐class human monoclonal antibody for the treatment of advanced solid tumours, binds to gremlin‐1 and restores bone morphogenetic protein signalling. We used pharmacokinetic/pharmacodynamic (PK/PD) modelling to characterize the relationship between ginisortamab dose and serum gremlin‐1 binding, using model‐based simulations ...
Yin Cheong Wong +6 more
wiley +1 more source
Functional neuroplasticity in chronic post-stroke aphasia following a singing intervention in a cross-over randomised trial. [PDF]
Martínez-Molina N +12 more
europepmc +1 more source
Advanced therapy medicinal products (ATMPs) – An analysis of the global regulatory status
Abstract Background A rapid progress in the development of advanced therapy medicinal products (ATMPs) has taken place over the past decades. The ATMPs hold great potential but face challenges in the clinical development and the regulatory process.
Allan Cramer +4 more
wiley +1 more source
Effectiveness of a five-component multimodal intervention on executive function in children with Autism spectrum disorder: A study protocol for a randomized controlled trial. [PDF]
Hossain KMA +6 more
europepmc +1 more source
Abstract To negotiate quality in early childhood education and care, we must ask from different perspectives what constitutes a good centre for children. The children themselves have only recently been identified as a resource to contribute to that discussion.
Katrin Macha +4 more
wiley +1 more source
Digital Humans for Depression Assessment and Intervention Support: Scoping Review.
Cao J +6 more
europepmc +1 more source
Does one size fit all? Developing an evaluation strategy to assess large language models for patient safety event report analysis. [PDF]
Fong A +5 more
europepmc +1 more source

