Results 151 to 160 of about 54,630 (220)

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

Contraindicated drug–drug interactions and associated adverse drug reactions in an observational cohort study of 4543 paediatric hospitalized patients

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
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 dose‐finding population pharmacokinetic/pharmacodynamic model of ginisortamab, an anti‐gremlin‐1 monoclonal antibody, in patients with solid tumours

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
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]

open access: yesSci Rep
Martínez-Molina N   +12 more
europepmc   +1 more source

Advanced therapy medicinal products (ATMPs) – An analysis of the global regulatory status

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
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

Making it explicit – Sustained shared thinking dialogue as a way to explore children's perspectives on quality in German early childhood education and care

open access: yesBritish Educational Research Journal, EarlyView.
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.

open access: yesJMIR Ment Health
Cao J   +6 more
europepmc   +1 more source

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