Results 191 to 200 of about 12,829 (249)

Early‐stage health technology assessment of a curative gene therapy for multiple sclerosis

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Multiple sclerosis (MS) is associated with significant early morbidity, reduced life expectancy and substantial healthcare and societal costs. The primary objective of this study is to assess the early cost‐effectiveness potential of a novel gene therapy, IMMUTOL, for MS compared with current high‐efficacy treatment sequences.
Attila Imre, Balázs Nagy, Rok Hren
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

Disaster Report - Petroleum Depot (HAZMAT) Fire and Mass-Casualty Event in Guinea-December 18, 2023. [PDF]

open access: yesPrehosp Disaster Med
Bah TT   +5 more
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

open access: yesBritish 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   +5 more
wiley   +1 more source

Influence of airway pressure release ventilation on pulmonary gas exchange using ventilatory ratio. [PDF]

open access: yesFront Med (Lausanne)
Kiratlar E   +8 more
europepmc   +1 more source

Development of a nalmefene formulation suitable for a community‐use auto‐injector

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim Time to onset of reversal is critical when treating opioid‐induced respiratory depression and hypoxia. This study aimed to develop a formulation of the opioid antagonist nalmefene with an increased absorption rate and reduced time to onset of reversal following intramuscular administration. Methods Several absorption enhancers were screened in rats,
Alessandra Cipriano   +6 more
wiley   +1 more source

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