Results 181 to 190 of about 38,749 (262)

Status of oncology drugs with a conditional approval: A cross‐sectional comparison of the Food and Drug Administration and Health Canada

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims This study looks at the status of the same drugs conditionally approved by the Food and Drug Administration and Health Canada for the same oncology indication. Methods Lists of oncology drugs with a conditional approval from the Food and Drug Administration and Health Canada were generated and drug pairs with the same indication were matched ...
Joel Lexchin
wiley   +1 more source

Do drugs approved via expedited approval pathways have therapeutic advantages? A systematic review and meta‐analysis

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Regulators use expedited approval pathways to speed market approval and patient access to promising new drugs. However, there is uncertainty about whether these pathways are successful in approving drugs with significant therapeutic advantages. This systematic review aims to examine the safety, effectiveness and cost‐effectiveness of drugs approved via
Ashleigh Hooimeyer   +4 more
wiley   +1 more source

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

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

Enhancing underwater sensor network security using QKD-enabled acoustic-optical hybrid communication. [PDF]

open access: yesSci Rep
Rajnarayanan S   +4 more
europepmc   +1 more source

Educational pathways and outcomes for care‐experienced children: A 16‐year longitudinal study

open access: yesBritish Educational Research Journal, EarlyView.
Abstract Children who are removed from their birth families during childhood—termed care‐experienced—can be at risk for lower educational attainment and poorer school experiences, often linked to deprivation and behavioural factors. However, research often uses aggregated measures that obscure the complexities of care (e.g.
Emily Lowthian   +9 more
wiley   +1 more source

‘I was treated as a deficit’: Immigrant teachers' career progression in Australia

open access: yesBritish Educational Research Journal, EarlyView.
Abstract Immigrant teachers have long been recruited through skilled and employer‐sponsored migration schemes to address teacher shortages in Australia, yet their career trajectories remain constrained by systemic inequities that limit their integration and professional development opportunities.
Ching Ting Tany Kwee   +2 more
wiley   +1 more source

Home - About - Disclaimer - Privacy