Results 151 to 160 of about 22,255,876 (302)

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

Regulatory harmonization: Evolution, globalization and future directions

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm   +2 more
wiley   +1 more source

Analysis of How the Term "Shall" Is Understood and Applied to the EU-HTA Regulation. [PDF]

open access: yesJ Mark Access Health Policy
Toumi M   +5 more
europepmc   +1 more source

Implementation and use of risk minimization control tools in the EU: A multistakeholder survey

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims This study characterized stakeholders' experiences with national implementation of risk minimization control tools (RMCTs), such as healthcare professional qualification, healthcare facility accreditation and medical intervention prior to treatment initiation, for eight medicinal products across eight European Union countries. Methods We conducted
Sharon C. M. Essink   +21 more
wiley   +1 more source

Paediatric clonidine medication errors: Findings from a multicentre French study

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims This study aimed to describe the characteristics of medication errors involving clonidine in paediatric patients and reported to French Network of Pharmacovigilance and Poison Control Centres. Methods This retrospective observational study analysed clonidine‐related medication errors reported between 1985 and June 2024 in patients under 12 years ...
Eve‐Marie Thillard   +8 more
wiley   +1 more source

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