Results 191 to 200 of about 1,228,818 (316)

The lack of legal protections in the United States to prevent commercializing the dead for education and research: Consequences and risks to anatomists

open access: yesAnatomical Sciences Education, EarlyView.
Abstract A lack of minimum legal standards for body donation programs undermines recent strides by anatomy professionals to promote ethical best practices in the United States (US). In particular, the commercialization of the dead by nontransplant tissue banks poses a risk to the public trust in academic body donation programs.
Laura E. Johnson
wiley   +1 more source

Effective Management of Late Inflammatory Nodules Following Hyaluronic Acid Fillers: A Case Series Treated With Methotrexate. [PDF]

open access: yesPlast Reconstr Surg Glob Open
Piccinini Colucii L   +3 more
europepmc   +1 more source

Essential work, invisible workers: The role of digital curation in COVID‐19 Open Science

open access: yesJournal of the Association for Information Science and Technology, Volume 76, Issue 4, Page 703-717, April 2025.
Abstract In this paper, we examine the role digital curation practices and practitioners played in facilitating open science (OS) initiatives amid the COVID‐19 pandemic. In Summer 2023, we conducted a content analysis of available information regarding 50 OS initiatives that emerged—or substantially shifted their focus—between 2020 and 2022 to address ...
Irene V. Pasquetto   +2 more
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

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

Zuranolone: A case study in (regulatory) rush to judgement?

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Sage, in collaboration with Biogen, submitted a new drug approval for zuranolone for postpartum depression (PPD) and major depressive disorder (MDD) in December 2022. In August 2023, the US Food and Drug Administration granted approval for PPD but denied approval for MDD.
Lisa Cosgrove   +4 more
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

Drivers of firm-government engagement for technology ventures. [PDF]

open access: yesPLoS One
Lanahan L   +3 more
europepmc   +1 more source

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