Results 201 to 210 of about 17,545,410 (298)

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

Benzodiazepines use in primary care England: Prescribing patterns and adverse consequences

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Benzodiazepines (BZDs) are commonly prescribed for anxiety and insomnia but carry risks such as dependence, adverse drug reactions (ADRs) and mortality. Despite deprescribing efforts, the influence of recent prescribing trends, COVID‐19 and adverse outcomes on prescribing patterns in England remains uncertain.
Alvina Chaudhry   +3 more
wiley   +1 more source

Reception Baseline Assessment and ‘small acts’ of micro‐resistance

open access: yesBritish Educational Research Journal, EarlyView.
Abstract In September 2021, following the global COVID‐19 pandemic, the Department for Education introduced a national standardised digital Reception Baseline Assessment (RBA) for all English 4‐year‐old children. We analyse RBA and its associated Quality Monitoring Visits, as a further intensification of the new public management of early years ...
Guy Roberts‐Holmes   +2 more
wiley   +1 more source

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