Results 191 to 200 of about 13,451,987 (316)

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

Zuranolone: A case study in (regulatory) rush to judgement?

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Sage, in collaboration with Biogen, submitted a new drug approval for zuranolone for postpartum depression (PPD) and major depressive disorder (MDD) in December 2022. In August 2023, the US Food and Drug Administration granted approval for PPD but denied approval for MDD.
Lisa Cosgrove   +4 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

Towards appropriate guidance for the ethical challenges of environmentally sustainable prescribing

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
The environmental impact of medicines poses a significant threat to planetary and public health, making it essential to integrate environmental sustainability into prescribing practices. While the most effective measures to reduce environmental impact, such as reducing unnecessary prescriptions and medication waste, are consistent with appropriate ...
Joost D. Piët   +22 more
wiley   +1 more source

How Often Do Pharmacists End up in Court? Analysis of Civil and Criminal Case Law in Poland. [PDF]

open access: yesHealthcare (Basel)
Merks P   +8 more
europepmc   +1 more source

The impact of the current student loans regime on Muslim student engagement and retention in English higher education

open access: yesBritish Educational Research Journal, EarlyView.
Abstract There is much interest in the potential for an alternative funding system for higher education students in England to support the spiritual and worldly needs of British Muslim students. At the heart of this issue lies a tension over whether the student financing system in English HE is haram, or forbidden under Islamic (Shari'ah) law, because ...
Richard Hall   +2 more
wiley   +1 more source

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