Results 251 to 260 of about 39,627 (302)

Technical evaluation of language models adapted for the automation of legal contracts: clause extraction, classification, and summarization. [PDF]

Front Artif Intell
Govea J, Ortiz-Gárces I, Palacios P, Navarro AM, Del Pino SA, Villegas-Ch W.   +5 more
europepmc   +1 more source

Beyond the label: Rethinking off‐label drug use in paediatrics. Towards a scientifically grounded and safer future for paediatric pharmacotherapy

British Journal of Clinical Pharmacology, EarlyView.
Abstract Despite regulatory progress being made in the past two decades, off‐label drug use in paediatrics remains pervasive, with prevalence estimated between 3% and 97% of prescriptions across different clinical settings. Off‐label use—defined as prescribing outside the conditions described in the Summary of Product Characteristics (SmPC)—is often ...
Tjitske M. van der Zanden, Miriam G. Mooij, Matthijs de Hoog, Saskia N. de Wildt   +3 more
wiley   +1 more source

Impacts of Plant Protection Products on Biodiversity: Limits of Risk Assessment and Avenues to Ground Liability. [PDF]

Risk Anal
Leenhardt S, Mamy L, Barthélémy C, Berny P, Bureau-Point E, Corio-Costet MF, Pesce S, Doussan I.   +7 more
europepmc   +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

Legal and Ethical Challenges in Integrating AI Into Clinical Practice: Qualitative Study of Physicians' Real-World Experiences. [PDF]

JMIR AI
Mostafapour M, Fortier J, Pacheco K, Murray H, Garber G.   +4 more
europepmc   +1 more source

Do drugs approved via expedited approval pathways have therapeutic advantages? A systematic review and meta‐analysis

British 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, Eliza J. McEwin, Zhicheng Wang, Joel Lexchin, Barbara Mintzes   +4 more
wiley   +1 more source

A study of Chinese law on restricting personal liberty for public health protection: taking the COVID-19 epidemic as the entry point. [PDF]

Front Public Health
Liu T, Ma Z.
europepmc   +1 more source

Exposure‐adjusted safety and efficacy of GLP‐I and GLP‐1/GIP receptor agonists compared with non‐GLP‐I for weight management and type 2 diabetes: Based on FDA medical and statistical reports of 34 280 safety and 36 312 efficacy subjects

British Journal of Clinical Pharmacology, EarlyView.
Aims This work aimed to contextualize glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) and glucose‐dependent insulinotropic polypeptide (GIP) receptor agonists safety and efficacy regarding weight management (WM); we analysed Food and Drug Administration (FDA) Medical Reviews to analyse 14 medications using patient‐exposure year normalization and ...
Aishwarya Prasad, Anshu Arora, Arun Arora, Jeena Vaid, Arif Khan   +4 more
wiley   +1 more source

Editorial: Optimizing the therapeutic potential in clinical settings: leveraging placebos and mitigating nocebo effects. [PDF]

Front Psychol
Faria V, Bernstein M, Annoni M, Furmark T, Moulton EA.   +4 more
europepmc   +1 more source