Results 121 to 130 of about 23,300 (250)

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

British 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, Attila Imre, Gábor Varga, Sándor Kovács, György Tímár, Balázs Nagy   +5 more
wiley   +1 more source

The HALO Model: A Learning Health System Framework for Artificial Intelligence. [PDF]

Learn Health Syst
Zai AH, Adibuzzaman M, McManus DD, Walkey A.   +3 more
europepmc   +1 more source

How the HTAR will contribute to a value‐based decision‐making for medicinal products across the EU

British Journal of Clinical Pharmacology, EarlyView.
The European Union Health Technology Regulation 2021/2282 (HTAR) introduces joint assessment of health technologies (including medicinal products and medical devices) across EU Member States. It was signed into law in 2021 and came into full force in January 2025.
Roisin Adams, Michal Stanak
wiley   +1 more source

From Concept to Claim: An Integrated Lifecycle Roadmap (ILR) for Patient-Centric Endpoints in Clinical Trials and Real-World Evidence. [PDF]

Healthcare (Basel)
Kardjadj M.
europepmc   +1 more source

PERICLES : Promoting and Enhancing Reuse of Information throughout the Content Lifecycle taking account of Evolving Semantics

, 2013
This poster paper describes the objectives, approach and use casesof the EC FP7 Integrated Project PERICLES. The project beganon 1st February 2013 and runs for four years. The aim is toresearch and prototype solutions for digital preservation incontinually evolving environments including changes in context,semantics and practices. The project addresses
Hedges, Mark, Waddington, Simon, Darányi, Sándor, Maceviciute, Elena, Wilson, Tom, Kompatsiaris, Yiannis, Dasiopoulu, Stamatia, Spyroglou, Odysseas, Ludwig, Jens, Wieder, Philipp, Watry, Paul, Hasan, Adil, Corubolo, Fabio, Pinchuk, Rani, Chanod, Jean-Pierre, Vion-Dury, Jean-Yves, Baxter, Rob, Laurenson, Pip, Muller, Christian   +18 more
openaire   +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

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

Beyond Terminator Narratives: Implantable Cardioverter-Defibrillators as a Lens for Clinical Agentic Artificial Intelligence. [PDF]

Mayo Clin Proc Digit Health
Modi SA.
europepmc   +1 more source

Active surveillance of drug safety in healthcare data: Sequential monitoring of bacterial and serious urinary tract infection risk in sodium‐glucose cotransporter 2 inhibitor users

British Journal of Clinical Pharmacology, EarlyView.
Abstract Introduction Active surveillance of adverse events using healthcare data is emerging as complementary to the monitoring of spontaneous reports and stand‐alone pharmacoepidemiologic studies. The risk of urinary tract infections (UTIs) was listed as a special warning for sodium‐glucose cotransporter‐2 inhibitors (SGLT2is) when marketed in Europe
Haoxin Le, Dilsad Simay Peker, Lukas Frederic Westphal, Nikolai Brun, Christine Erikstrup Hallgreen, Morten Andersen   +5 more
wiley   +1 more source

Academic misconduct appeal services in China: Platform logics, self‐platformization and implications for integrity education

British Educational Research Journal, EarlyView.
Abstract Academic misconduct appeal services have quietly emerged within China's education marketplace, with commercial agencies promoting themselves on social media to assist international students facing misconduct hearings. While existing research on academic integrity has emphasized prevention and detection, far less attention has been paid to what
Gengyan Tang, Sarah Elaine Eaton, Wei Cai   +2 more
wiley   +1 more source

Pediatric Clinical Images Without Consent: A Governance Gap in the Long-Term Reuse of Health Data in Digital Health Ecosystems. [PDF]

J Med Internet Res
Bujek I.
europepmc   +1 more source