Results 161 to 170 of about 254,085 (269)

Characteristics and temporal trends of EU teratological safety signals and information dissemination to healthcare professionals in the Netherlands—A contribution of the ConcePTION project

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Although regulatory responses to safety signals have been studied, pregnancy‐specific data and their dissemination to medical professionals remain unclear. This study examined the characteristics and temporal trends of teratological safety signals prompting the European Medicines Agency to implement risk minimization measures.
Yrea R. J. van Rijt‐Weetink   +9 more
wiley   +1 more source

Do consumers and healthcare professionals report the same adverse event differently? A paired analysis of duplicate vaccine safety reports in Norway

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim This study aimed to compare how Norwegian healthcare professionals (HCPs) and consumers reported the same adverse event (AE) following immunization with vaccines against COVID‐19 during the COVID‐19 pandemic. Specifically, we aimed to compare the extent to which HCPs and consumers reported information relevant for assessing the causal relationship ...
Tommy Emil Dzus   +4 more
wiley   +1 more source

A university‐certified course on dossier assessment for regulatory scientists in Africa—Reporting on our 5‐year experience

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim The shortage of trained clinical assessors in African National Regulatory Authorities (NRAs) poses a challenge to effective regulatory decision‐making. Developed in line with the World Health Organization's (WHO) Global Competency Framework (WHO‐GCF), a university‐certified short course, Dossier assessment for clinical assessors in Africa, was ...
Stephanie Leigh   +19 more
wiley   +1 more source

MT‐RNR1 genotype testing for preventing aminoglycoside‐mediated ototoxicity: A guideline developed by the UK Centre of Excellence in Regulatory Science and Innovation in Pharmacogenomics (CERSI‐PGx)

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aminoglycosides are broad‐spectrum antibiotics used in the management of severe infections. Aminoglycosides are associated with nephrotoxicity and ototoxicity. Although dosing strategies such as once‐daily administration and therapeutic drug monitoring have reduced the incidence of nephrotoxicity, ototoxicity remains unpredictable and may occur at ...
John H. McDermott   +16 more
wiley   +1 more source

Capacity building in medicines development and regulation in Africa—Overview on recent progress

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Despite advances in health research and digital innovation, many African countries continue to face substantial resource constraints, fragmented capacity‐building efforts and a shortage of skilled professionals in medicines development and regulatory science.
Tirhani Maluleke   +7 more
wiley   +1 more source

Long‐acting cabotegravir and rilpivirine in people with HIV receiving chronic anticoagulation: A real‐world case series

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Background Long‐acting intramuscular cabotegravir plus rilpivirine (LA‐CAB + RPV) is an effective maintenance antiretroviral regimen for virologically suppressed people with HIV. However, its use in individuals receiving chronic anticoagulation is limited by concerns regarding intramuscular bleeding risk, and real‐world data are scarce.
Montserrat Laguno   +13 more
wiley   +1 more source

Young children's right to be heard on the quality of their education: Addressing potential misunderstandings in the context of early childhood education

open access: yesBritish Educational Research Journal, EarlyView.
Abstract In early childhood education many researchers and professionals across the world have embraced the United Nations Convention on the Rights of the Child's requirement to include young children in decision‐making. In the context of ongoing discussion about young children's capacity to share their views and opinions about matters affecting them ...
Laura Lundy   +3 more
wiley   +1 more source

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