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Biosimilars: A Critical Review of Development, Regulatory Landscape, and Clinical Implications.
AAPS PharmSciTech
January 2025
School of Pharmaceutical Sciences, Delhi Pharmaceutical Sciences and Research University, New Delhi, India, 110017.
The biopharmaceutical industry has witnessed significant growth in the development and approval of biosimilars. These biosimilars aim to provide cost-effective alternatives to expensive originator biosimilars, alleviating financial pressures within healthcare. The manufacturing of biosimilars is a highly complex process that involves several stages, each of which must meet strict regulatory standards to ensure that the final product is highly similar to the reference biologic.
View Article and Find Full Text PDFIntroduction: The most frequent form of diabetes in pediatric patients is polygenic autoimmune diabetes (T1D), but single-gene variants responsible for autoimmune diabetes have also been described. Both disorders share clinical features, which can lead to monogenic forms being misdiagnosed as T1D. However, correct diagnosis is crucial for therapeutic choice, prognosis and genetic counseling.
View Article and Find Full Text PDFComparison of efficacy between micro-osteoperforations and alveolar corticotomies on the rate of orthodontic tooth movement: A systematic review and meta-analysis.
J Craniomaxillofac Surg
January 2025
Universidad Europea de Valencia, Faculty of Health Sciences, Department of Dentistry, Valencia, Spain; Universidad de Valencia, Faculty of Medicine and Dentistry, Department of Orthodontics, Valencia, Spain. Electronic address:
Micro-osteoperforations and corticotomies are two surgical techniques commonly used to increase the rate of tooth movement. The aim of this systematic review was to respond to the question: Which method used for accelerating orthodontic tooth movement, micro-osteoperforations or alveolar corticotomy, produces a higher rate of tooth movement and present less adverse effects? Searches were performed in the electronic databases of PubMed, Scopus, Cochrane CENTRAL, Web of Science, Lilacs and Science Direct, as well as grey literature (Opengrey), up to March 2024. All the included studies were controlled, randomized clinical trials, cohort, case-control, cross-sectional, and multicentre studies of patients treated with orthodontics and corticotomies or micro-osteoperforations.
View Article and Find Full Text PDFHow to: share and reuse data - challenges and solutions from PrIMAVeRa project.
Clin Microbiol Infect
January 2025
Infectious Diseases and Microbiology Division, Hospital Universitario Virgen Macarena; Department of Medicine, University of Seville; Instituto de Biomedicina de Sevilla (IBiS)/Consejo Superior de Investigaciones Científicas (CSIC), Seville, Spain; CIBERINFEC, Instituto de Salud Carlos III, Madrid, Spain.
Background: Data sharing accelerates scientific progress and improves evidence quality. Even though journals and funding institutions require investigators to share data, only a small part of studies made their data publicly available upon publication. The procedures necessary to share retrospective data for re-use in secondary data analysis projects can be cumbersome.
View Article and Find Full Text PDFPilot of a joint bed-side teaching course for medical and pharmacy university students.
Pharmazie
December 2024
Drug Safety Center, Medical Faculty, Leipzig University and Leipzig University Hospital, Germany.
: Interprofessional education of medical and pharmacy students may improve competence-based university teaching. : We developed a joint bed-side teaching to improve patient-related competencies in identifying drug-related problems in hospitalized patients at a university cardiology department. Students were randomly allocated in mixed teams of medical and pharmacy students (1:3).
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