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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 PDFValproate discontinuation in girls and women of childbearing age with epilepsy: An Italian multicenter retrospective study on prescribing patterns and outcomes.
Epilepsia
January 2025
IRCCS Institute of Neurological Sciences of Bologna, Full Member of the European Reference Network EpiCARE, Bologna, Italy.
Objective: This study aimed to identify prescribing behaviors in women of childbearing potential (WOCP) with epilepsy already taking valproate (VPA), and to investigate the relationship between VPA maintenance, substitution, reduction, or withdrawal as part of polytherapy, and seizure worsening or relapse.
Methods: We retrospectively reviewed the prescription behaviors and seizure outcomes in WOCP (16-50 years of age) with epilepsy, referred to eight Italian epilepsy centers, who were taking VPA for at least 1 year between 2014 and 2019.
Results: Among 750 women (~12% of all WOCP), 528 (70.
Areas of modernization of the system of training and certification of forensic experts in Ukraine based on the adaptation of foreign experience.
Forensic Sci Res
December 2024
Department of Political Science and Law, Kyiv National University of Construction and Architecture, Kyiv, Ukraine.
Unlabelled: The article is devoted to the study of the existing system of training and certification of forensic experts in Ukraine and to the provision of proposals for its modernization, taking into account the positive experience in the field of forensic science of the USA, UK and some countries of the European Union. In Ukraine, the procedure for the training and certification of forensic experts is determined by ministries and other central executive authorities, which manage state specialized institutions that carry out forensic activities. A study of foreign experience in the training and certification of forensic experts made it possible to identify general and specific elements, sustain the benefits of the implemented measures, and formulate priorities and guidelines.
View Article and Find Full Text PDFUpdate in Clinical Science: Autoimmune Hepatitis.
J Hepatol
January 2025
I. Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany; European Reference Network on Hepatological Diseases (ERN RARE-LIVER). Electronic address:
Autoimmune hepatitis (AIH) is an enigmatic, relatively rare disease with a variable spectrum of presentation whose pathogenesis, diagnosis and management remain a major challenge. Methods. We have performed a review incorporating recent developments in basic science, epidemiology, clinical science, therapeutics, regulatory science and evaluated the challenges associated with the application of translational research and clinical trial design to a condition that is a chameleon in nature, where outcomes range from relatively benign disease through cirrhosis and acute liver failure.
View Article and Find Full Text PDFToward Product Safety and Circularity: Understanding the Information Structure of Global Databases on Chemicals in Products and Articles.
Environ Sci Technol
January 2025
RECETOX, Faculty of Science, Masaryk University, Kotlářská 2, 611 37 Brno, Czechia.
Access to information about chemicals in products and articles is critical for supporting enforcement of chemical regulations, assessing risks from chemicals, allowing informed consumer choices, and enabling product circularity. In this work, we identified and evaluated available databases (DBs) on chemicals in products and articles from the literature using a defined protocol and from European national market surveillance authorities, nongovernmental agencies, and industrial sector groups using questionnaires. This is the first comprehensive review of DBs that provide information about chemicals in products and articles.
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