Results 201 to 210 of about 2,988,114 (258)

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

Overmedicalisation of childhood: what paediatricians and child health professionals <i>can</i> <b>do</b>. [PDF]

open access: yesBMJ Paediatr Open
Liao L   +6 more
europepmc   +1 more source

Development of an artificial intelligence-based algorithm for the detection of left atrial enlargement from feline thoracic radiographs. [PDF]

open access: yesVet Q
Valente C   +11 more
europepmc   +1 more source

TiRank prioritizes phenotypic niches in tumor microenvironment for clinical biomarker discovery. [PDF]

open access: yesGenome Med
Lin Y   +17 more
europepmc   +1 more source

Leveraging Large-Scale Public Data for Artificial Intelligence-Driven Chest X-Ray Analysis and Diagnosis. [PDF]

open access: yesDiagnostics (Basel)
Khan FK   +6 more
europepmc   +1 more source

Mapping the political landscape from data traces: Multidimensional opinions of users, politicians and media outlets on X. [PDF]

open access: yesData Brief
Vendeville A   +11 more
europepmc   +1 more source

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