Results 181 to 190 of about 3,044,103 (290)

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

The impact of medication shortages on paediatric care: A retrospective impact analysis

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Medication shortages are a growing global concern, with potentially greater consequences in paediatric patients because of the limited availability of safe, evidence‐based and appropriately formulated medication. This study aimed to evaluate the impact of medication shortages on paediatric patients by assessing the suitability and safety of ...
Maaike Johanna Rutten ‐ van Kranenburg   +6 more
wiley   +1 more source

Plasma and breast milk pharmacokinetics of suvorexant in healthy lactating women

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim This paper aims to evaluate the plasma and breast milk pharmacokinetics of suvorexant, an orexin receptor antagonist used to treat insomnia at a maximum dose of 20 mg, in healthy lactating women. Methods The paper reports on an open‐label Phase 1 study in 12 healthy lactating women.
Jacqueline McCrea   +10 more
wiley   +1 more source

Causality assessment tool for drug‐induced acute kidney injury in patients admitted to intensive care units: Requirements from a multicentre retrospective study in the Netherlands reusing data from electronic health records

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim This study aimed to provide key requirements for a drug‐induced acute kidney injury (d‐AKI) causality assessment tool (CAT) for intensive care unit (ICU) patients, using vancomycin‐induced AKI (v‐AKI) as a test case. Methods A retrospective review was conducted by medical experts of electronic health records of ICU patients from 14 Dutch ICUs.
Joanna E. Klopotowska   +44 more
wiley   +1 more source

Opinion Leadership among Nurses in Public Debate: Moral Conviction, Credibility, and Collective Support. [PDF]

open access: yesPolicy Polit Nurs Pract
Spoolder DAE   +3 more
europepmc   +1 more source

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