Results 231 to 240 of about 31,203 (302)

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

British 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, Aleksandar Gigov, Hubertus G. M. Leufkens, Andrew Bate, Marie Louise De Bruin, Helga Gardarsdottir   +5 more
wiley   +1 more source

Communication access, public health information sources, and language preference during the COVID-19 pandemic in Indigenous communities in Northwest Territories, Canada. [PDF]

PLoS One
Harris R, Kolahdooz F, Omidimorad A, Wagg A, DeLancey D, Kandola K, Pirkola S, Irlbacher-Fox S, Corriveau A, Sharma S.   +9 more
europepmc   +1 more source

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

British 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, Caroline S. Copeland, Georgia C. Richards   +2 more
wiley   +1 more source

Promoting secure Firearm storage: The role of the media in reporting on unintentional Firearm deaths among children. [PDF]

J Public Health Res
Bordelon A, Corrigan L, Hammig B.
europepmc   +1 more source

Increasing the reporting of adverse drug reaction‐related hospitalizations using an ICD‐10‐based identification workflow: A multicentre study from Switzerland

British Journal of Clinical Pharmacology, EarlyView.
Background Reporting adverse drug reactions (ADRs) is essential for drug safety. In Switzerland, healthcare professionals are legally required to report serious and unlabelled ADRs, yet under‐reporting remains widespread. We tested a novel method to increase reporting of ADR‐related hospitalizations.
Georgia Anita Weber, Sophie‐Charlotte Bartel, Michael Boch, Christoph Rosen, Michael Bodmer, Balthasar Luzius Hug, Thomas Stammschulte, Patrick E. Beeler   +7 more
wiley   +1 more source

Celestinesca's new website!

, 2021
openaire   +2 more sources

Efficient information extraction using LLMs and knowledge distillation: A study on HPV health communication. [PDF]

PLOS Digit Health
Khan SH, Lybarger K.
europepmc   +1 more source

Advanced therapy medicinal products (ATMPs) – An analysis of the global regulatory status

British Journal of Clinical Pharmacology, EarlyView.
Abstract Background A rapid progress in the development of advanced therapy medicinal products (ATMPs) has taken place over the past decades. The ATMPs hold great potential but face challenges in the clinical development and the regulatory process.
Allan Cramer, Freja Karuna Hemmingsen Sørup, Marie Lund, Tonny Studsgaard Petersen, Kristian Karstoft   +4 more
wiley   +1 more source

Understanding psychiatrist readiness for AI: a study of access, self-efficacy, trust, and design expectations. [PDF]

BMC Health Serv Res
He Y, Zhang FX, Wu X, Fang M, Zheng S, Zhu H.   +5 more
europepmc   +1 more source