Results 141 to 150 of about 45,859 (253)

Optimization of pharmaceutical research and development by early‐phase assessment of investigational medicinal products

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Small and mid‐sized pharmaceutical innovators often have limited in‐house health economics and market access expertise, and may struggle to align development strategies of investigational medicinal products with health system needs and payer expectations.
Zoltán Kaló   +5 more
wiley   +1 more source

Pentoxifylline dose finding trial in preterm neonates with suspected late onset sepsis (PTX‐trial)

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim The aim of this study (PTX‐trial) is to determine the optimal dose of pentoxifylline (PTX) in preterm neonates (gestational age < 30 weeks) with (suspected) late onset sepsis (LONS). Methods The PTX‐trial is a prospective multicentre open‐label sequential dose‐optimization study with an adapted continual reassessment method.
Serife Kurul   +7 more
wiley   +1 more source

Possible therapeutic repositioning of valproic acid: From epileptic seizures to acute kidney injury

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Valproic acid, an anticonvulsant, may be repositioned to prevent acute kidney injury due to ischemia followed by reperfusion. It preserves renal functions, electrolyte homeostasis and active sodium transport in kidney tubules, and blocks the onset of hypertension.
Danilo Alves‐Bezerra   +8 more
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

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

Mechanisms to medicines: navigating drug repurposing strategies in Alzheimer's disease. [PDF]

open access: yesFront Aging Neurosci
Khan SA   +5 more
europepmc   +1 more source

Comparative efficacy of GLP‐1 RA, tirzepatide and SGLT‐2 inhibitors in metabolic liver disease: A network meta‐analysis

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim Metabolic liver disease, including nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis, is a major cause of chronic liver dysfunction worldwide, creating an urgent need for effective treatments. This systematic literature review (SLR) and network meta‐analysis (NMA) systematically reviews and compares the efficacy and safety ...
Andrej Belančić   +8 more
wiley   +1 more source

Drug repurposing

open access: yesScience, 2020
openaire   +1 more source

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