Results 221 to 230 of about 6,287,315 (268)

When hospitals build their own AI: a comparison of the EU and US regulatory framework. [PDF]

BMJ Digit Health Ai
Palmieri S, Minssen T, Cohen IG.
europepmc   +1 more source

Regulatory Research Priorities for AI Use in the Medicine Lifecycle: A European Perspective with Global Relevance

Clinical Pharmacology &Therapeutics, EarlyView.
Regulatory bodies play a central role in providing guidance that enables safe and effective use of artificial intelligence tools in medicine development and evaluation. Regulators can also act as catalysts for regulatory science research. To inform these efforts, a European‐wide survey was conducted to solicit stakeholder perspectives on the priority ...
Luis C. Pinheiro, Amanda C. Langston, Marie Orre, Joerg Zinserling, Konstantina Boumaki, Bastian V. H. Hornung, Siobhan O'Sullivan, Gabriel Westman, Karl Broich, Peter Arlett   +9 more
wiley   +1 more source

High Awareness, Low Clarity: Knowledge of the Australian Capital Territory's Multi-Drug Decriminalisation Reform Among People Who Use Illicit Drugs. [PDF]

Drug Alcohol Rev
Sutherland R, Graham C, Hughes CE, Olsen A, Gough C, King C, Peacock A.   +6 more
europepmc   +1 more source

Maternal and Neonatal Complications Associated with Breast Cancer Systemic Treatments—A VigiBase Disproportionality Analysis Study

Clinical Pharmacology &Therapeutics, EarlyView.
Pregnancy‐associated breast cancer (PrBC) presents therapeutic challenges. Understanding maternal–fetal safety of systemic anticancer therapies is critical. We performed a case/non‐case disproportionality analysis using the WHO global pharmacovigilance database up to January 2024, to evaluate maternal–fetal outcomes associated with breast cancer (BC ...
Rayan Kabirian, Floriane Jochum, Elise Dumas, Florence Coussy, Kevin Bihan, Bénédicte Lebrun‐Vignes, Barbara Pistilli, Marc‐Antoine Benderra, Lise Selleret, Laurent Chouchana, Fabien Reyal, Anne‐Sophie Hamy, Paul Gougis   +12 more
wiley   +1 more source

Policy Silences and the Case for Dedicated Legislation for Street Sweepers in India: Policy Content Analysis using the READ Approach. [PDF]

Indian J Community Med
Selvaraj G, Elangovan APD, Subramani S, Thulasingam M.   +3 more
europepmc   +1 more source

Toward Fit‐for‐Purpose Data for Drug Assessment in Non‐small Cell Lung Cancer: A Core Dataset

Clinical Pharmacology &Therapeutics, EarlyView.
Considering the high unmet medical need in people with non‐small cell lung cancer (NSCLC), the drug assessment for targeted therapies often rely on small populations and single‐arm trials, challenging the evaluation by regulatory authorities, health technology assessment bodies (HTAb), and clinicians.
Geeske F. Grit, Maaike van Dartel, Laura Rodwell, Hanneke van der Woude, Cornelis Boersma, Peter G. M. Mol, Doranne Hilarius   +6 more
wiley   +1 more source

Analyzing state dyslexia legislation through the lens of oral language: an exploratory study. [PDF]

Ann Dyslexia
Georgan WC.
europepmc   +1 more source

In Silico Clinical Trials in Drug Development: Virtual Patients, Applications, and Regulatory Convergence

Clinical Pharmacology &Therapeutics, EarlyView.
Conventional clinical trials remain the benchmark for evaluating therapeutic safety and efficacy, yet they are constrained by escalating costs, withdrawal over the extended follow‐up periods, recruitment difficulties, ethical limits, and a restricted ability to characterize heterogeneous populations.
Maximilian Balmus, Sheng‐Ya Wang, Edward W. G. Ashton, Rosie K. Barrows, Molly Monks, Yuzhang Ge, Arthur Lefebvre, Steven A. Niederer   +7 more
wiley   +1 more source

Changing contexts of death and dying: Influence of the COVID-19 pandemic and voluntary assisted dying legislation on death literacy in Australia. [PDF]

Palliat Care Soc Pract
Shrestha S, Grindrod A, Lee S, Noonan K.
europepmc   +1 more source