Results 221 to 230 of about 1,621,781 (300)

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola   +5 more
wiley   +1 more source

Messaging Informed by Behavioral Economics and Representativeness in Clinical Research Enrollment: Four Randomized Clinical Trials.

open access: yesJAMA Netw Open
Fanaroff AC   +13 more
europepmc   +1 more source

Safety concerns reported by coroners following fentanyl patch fatalities in England, Wales and Northern Ireland between 1997 and 2024

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aim To identify safety concerns reported by coroners following fentanyl patch‐related deaths in England, Wales and Northern Ireland, and determine differences in coronial reporting. Methods A systematic case series linking the National Programme on Substance Use Mortality (NPSUM) and the Preventable Deaths Tracker (PDT) (https ...
Eman Mshari   +2 more
wiley   +1 more source

Detecting and Preventing Fraudulent Participation in Qualitative Research: Content Analysis of Two Multisite Studies. [PDF]

open access: yesJ Med Internet Res
Harden D   +20 more
europepmc   +1 more source

British National Formulary Guidance on prescribing in pregnancy: A descriptive cross‐sectional study

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim To assess how well pregnancy‐specific guidance within the British National Formulary supports healthcare professionals to facilitate safe and effective medication use. Methods We performed a manifest content analysis of the text of all pregnancy sections within British National Formulary drug monographs, with inductive and iterative coding.
Hannah Johnson   +9 more
wiley   +1 more source

Evaluating a virtual paediatric adverse drug reaction clinic

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Adverse drug reactions (ADRs) are a common problem in paediatric health care. There is limited access to expertise in the evaluation and management of potential ADRs in children, limiting access to these services and creating delays in assessment and management.
Emily Hauck   +2 more
wiley   +1 more source

Awareness of the Black Triangle Scheme among healthcare professionals and consumers in Australia: A mixed‐methods study exploring reporting intentions and suggested improvements

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims The Black Triangle Scheme, introduced in 2018 in Australia, does not appear to have increased the quantity of adverse drug event (ADE) reports. This study evaluated healthcare professionals' (HCPs') and consumers' awareness of the scheme, its influence on intentions for future ADE reporting, and suggested improvements.
Eyob Alemayehu Gebreyohannes   +7 more
wiley   +1 more source

Home - About - Disclaimer - Privacy