Editorial: European partnership on the assessment of risks from chemicals (PARC): continued focus on new approach methodologies (NAMs) and data gap filling. [PDF]
Beronius A, Roggen E, Svingen T.
europepmc +1 more source
ABSTRACT Objective Treatment of disorders of consciousness (DoC) remains a major clinical challenge, and noninvasive, targeted modulation of deep brain structures has emerged as a promising therapeutic strategy. We aimed to evaluate the feasibility/safety and preliminary effects of thalamic temporal interference stimulation (TIS) targeting centromedian‐
Gengyao Hu +7 more
wiley +1 more source
FDA/CDER/OND Experience With New Approach Methodologies (NAMs). [PDF]
Yao J +8 more
europepmc +1 more source
Modern Management of Asymptomatic Carotid Stenosis: A Meta‐Analysis of CREST‐2, SPACE‐2, and ECST‐2
ABSTRACT Background Recent randomized trials (CREST‐2, SPACE‐2, and ECST‐2) have compared carotid revascularization (carotid endarterectomy [CEA] or carotid artery stenting [CAS]) plus contemporary medical therapy (CMT) versus CMT alone in asymptomatic carotid stenosis.
Aasim Ali +14 more
wiley +1 more source
Extracellular Vesicles as Enabling Biomarkers for New Approach Methodologies to Support the US Food and Drug Administration Modernization Act 3.0. [PDF]
Rowland A +9 more
europepmc +1 more source
ABSTRACT Objective The prognosis of glioblastoma (GBM) remains highly unfavorable, largely due to high tumor heterogeneity and an immunosuppressive microenvironment. However, the functional role of PANoptosis in this context is poorly understood. Methods Patients were stratified via K‐means clustering. A risk score model was constructed using prognosis‐
Langfei Tian +6 more
wiley +1 more source
From animal testing to model-informed drug development: building on ICH M15 and EMA initiatives to make new approach methodologies (NAMs) deliver. [PDF]
Dogné JM +3 more
europepmc +1 more source
ABSTRACT Objective To describe long‐term outcomes after anti‐CD20 discontinuation in selected patients with secondary progressive multiple sclerosis (SPMS) who remained without subsequent disease‐modifying therapy (DMT). Methods We retrospectively analyzed data from four centers in Austria and Switzerland.
Ferdinand Otto +12 more
wiley +1 more source
Molecular Diagnosis to Individualized Therapies in Rare Genetic Diseases: New Approach Methodologies, RNA Therapeutics, and the Case for a Human-First Filter. [PDF]
Anwar S, Yokota T.
europepmc +1 more source
“Low‐Positive” MOG‐IgG Cases Among Adults With a First Event Suggestive of Multiple Sclerosis
ABSTRACT Objective To determine the prevalence and clinical characteristics of patients with “low‐positive” (LP) MOG‐IgG (titres 1:160–1:320) among adults with a first demyelinating event (FDE) suggestive of multiple sclerosis (MS). Methods From the Barcelona CIS inception cohort, we included adult patients with serum collected ≤ 6 months from the FDE.
Javier Villacieros‐Álvarez +29 more
wiley +1 more source

