Results 191 to 200 of about 2,766,237 (346)

Setting up mother–infant pair lactation studies with biobanking for research according to regulatory requirements

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Within the ConcePTION project we set out to design two mother–infant pair studies collecting breast milk and plasma from the mother and plasma from the infant (for metformin and prednisolone) in order to demonstrate the premises and conditions for investigating potential drug transfer in association with breastfeeding.
Mats Hansson   +11 more
wiley   +1 more source

Evaluation of the Medicines and Healthcare products Regulatory Agency's introduction of a risk‐proportionate approach for clinical trials: An analysis of 4617 applications assessed between September 2023 and August 2024

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims The Medicines and Healthcare products Regulatory Agency (MHRA) introduced a risk‐proportionate approach to assess clinical trial applications for authorisation in August 2023. This study evaluates the impact of this approach on the timelines for reviewing proposals.
Andrea Manfrin   +6 more
wiley   +1 more source

An open‐label, single‐arm, dose‐escalating concentration–QT study to investigate the cardiac effects and safety of paroxetine in healthy adults

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Paroxetine is a selective serotonin reuptake inhibitor (SSRI), approved for treatment of major depressive disorder and anxiety disorders. Some SSRIs are known to prolong the QT interval; however, clinical evidence to establish a lack of association between paroxetine and corrected QT interval (QTc) prolongation is limited. Therefore, this
Sven C. van Dijkman   +6 more
wiley   +1 more source

Low‐intervention clinical trials in Spain: Do they progress?

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Low‐Intervention Clinical Trials (LICTs) are generally pragmatic trials that investigate medicinal products already authorized for use. In 2014, simplified regulatory frameworks were introduced for LICTs with the aim of reducing regulatory burden and operational complexity, to foster non‐commercial clinical trials (NCCTs); the mandatory ...
Claudia Erika Delgado‐Espinoza   +4 more
wiley   +1 more source

‘Where are the adults?’: Troubling child‐activism and children's political participation

open access: yesBritish Educational Research Journal, EarlyView.
Abstract Children's political participation is a well‐established theme in childhood studies. In this article we offer an original account of child activism that takes into account the entangled and emergent aspect of children as activists. We begin with a historical and a conceptual review, noting the importance of mid‐20th century developments such ...
Sharon Hunter, Claire Cassidy
wiley   +1 more source

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