Results 201 to 210 of about 2,281,199 (281)

“You're this person who's providing light”: Embodied responses to information loss and transition within LGBTQIA+ communities

open access: yesJournal of the Association for Information Science and Technology, EarlyView.
Abstract This paper reports on findings from 15 semi‐structured interviews with LGBTQIA+ individuals within the United States who have experienced the loss of one or more LGBTQIA+ information spaces. The paper specifically focuses on how such losses occurred and the information transitions experienced by the participants in response to this loss ...
Travis L. Wagner, Vanessa L. Kitzie
wiley   +1 more source

Optimization of pharmaceutical research and development by early‐phase assessment of investigational medicinal products

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Small and mid‐sized pharmaceutical innovators often have limited in‐house health economics and market access expertise, and may struggle to align development strategies of investigational medicinal products with health system needs and payer expectations.
Zoltán Kaló   +5 more
wiley   +1 more source

Age‐related differences in hydroxychloroquine‐associated adverse events: A pharmacovigilance study based on the FDA Adverse Event Reporting System

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims This real‐world pharmacovigilance study utilizes FDA Adverse Event Reporting System (FAERS) data (2004–2024) to characterize age‐related disparities in hydroxychloroquine (HCQ)‐associated adverse events (AEs), addressing gaps in age‐stratified risk assessment. Methods Disproportionality analysis (reporting odds ratios, RORs) and parametric Weibull
Guanghan Sun   +4 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

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

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