Results 131 to 140 of about 21,350 (239)

The role of premorbid cognitive performance in the neuropsychological assessment of people with HIV in South Africa. [PDF]

open access: yesPLoS One
Dreyer AJ   +6 more
europepmc   +1 more source

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

A framework for developing successful academic-industry partnerships for cardiovascular innovations. [PDF]

open access: yesHeart Rhythm O2
Steltzer SS   +5 more
europepmc   +1 more source

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

Interoperability architecture for data spaces. [PDF]

open access: yesData Brief
Soininen JP   +8 more
europepmc   +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

Impact of the pancreatic enzyme replacement therapy (PERT) shortage on prescribing in England: Analysis of national data

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim Pancreatic enzyme replacement therapy (PERT) is essential for the management of pancreatic exocrine insufficiency. Since June 2023, the United Kingdom has been affected by a global shortage of PERT. We investigated the impact of this shortage on national prescribing trends for Creon, Nutrizym, Pancrex and Pangrol.
Teena S. Varghese   +6 more
wiley   +1 more source

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