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Harnessing the AI/ML in Drug and Biological Products Discovery and Development: The Regulatory Perspective.
Pharmaceuticals (Basel)
January 2025
College of Pharmacy, University of Illinois, Chicago, IL 60612, USA.
Artificial Intelligence (AI) has the disruptive potential to transform patients' lives via innovations in pharmaceutical sciences, drug development, clinical trials, and manufacturing. However, it presents significant challenges, ethical concerns, and risks across sectors and societies. AI's rapid advancement has revealed regulatory gaps as existing public policies struggle to keep pace with the challenges posed by these emerging technologies.
View Article and Find Full Text PDFDiagnostic Algorithm Using Multimodal Imaging for the Differential Diagnosis of Intra-Cardiac Masses.
J Clin Med
January 2025
Department of Cardio-Thoracic-Vascular Diseases, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122 Milan, Italy.
Cardiac masses are complex clinical conditions that frequently pose diagnostic challenges in cardiology practice. These masses can form within heart chambers or near the pericardium and are generally categorized as either non-neoplastic or neoplastic. These latter are further classified into benign and malignant (primary and secondary or metastatic).
View Article and Find Full Text PDFA Multidisciplinary Approach to Diagnosing Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN): Practical Recommendations and Insights from Countries of the Gulf Cooperation Council.
Cancers (Basel)
January 2025
ARUP Laboratories, Department of Pathology, University of Utah, Salt Lake City, UT 84103, USA.
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is an aggressive orphan hematopoietic malignancy characterized by cutaneous and systemic hematologic involvement. BPDCN is frequently misidentified, but early, accurate diagnosis is critical to extending patient survival using tagraxofusp, a first-in-class CD123-targeted therapy, and increasing their chances of receiving a potentially curative stem cell transplantation. Cases of BPDCN in countries of the Gulf Cooperation Council are lower than the extrapolated incidence from other geographic locations due to lack of awareness of key diagnostic features, lack of consensus on the minimal phenotype for diagnosis, and lack of local immunohistochemistry testing facilities, contributing to underdiagnosis in this region.
View Article and Find Full Text PDFInitial surgical management of spinal injuries in patients with multiple and/or severe injuries- the 2022 update of the German clinical practice guideline.
Eur J Trauma Emerg Surg
January 2025
Centre of Spinal Cord Injuries, BG Murnau Trauma Centre, Murnau, Germany.
Purpose: Our aim was to update evidence-based and consensus-based recommendations for the initial surgical management of spinal (cord) injuries in patients with multiple and/or severe injuries based on current evidence. This guideline topic is part of the 2022 update of the German Guideline on the Treatment of Patients with Multiple and/or Severe Injuries.
Methods: MEDLINE and Embase were systematically searched to May 2021.
[Translated article] The relevance of therapeutic positioning in the post-approval evaluation of new drugs.
Farm Hosp
January 2025
Servicio de Farmacia, Hospital Universitario Puerto Real, Cádiz, Spain.
The objective of regulatory authorities is to ensure a favourable risk-benefit balance for medicines in their licenced indication, without seeking to establish their place in the therapeutic armamentarium beyond that. The licenced indication covers heterogeneous subpopulations and often does not sufficiently specify the characteristics of the patients who may benefit. The regulatory information does not always show the benefit over the standard treatment(s); moreover, it only reacts to the conditions specified in the developer's application, and lacks an assessment of the clinical relevance of the benefit and its uncertainties.
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