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Titanium nanostructure mitigating doxorubicin-induced testicular toxicity in rats via regulating major autophagy signaling pathways.
Toxicol Rep
June 2025
Therapeutic Chemistry Department, Pharmaceutical and Drug Industries Research Institute, National Research Centre, El Buhouth St., Dokki, Cairo 12622, Egypt.
Doxorubicin (DOX) is a powerful antineoplastic FDA-approved anthracycline-derived antibiotic and is considered as the most suitable intervention for solid tumors and hematological cancers therapy. However, its therapeutic application is highly limited due to acute and chronic renal, hematological and testicular toxicity. Oxidative stress, lipid peroxidation and apoptosis in germ cells as well as low sperm count, motility and disturbing steroidogenesis are the principal machineries of DOX-induced testicular toxicity.
View Article and Find Full Text PDFCondition monitoring and fault classification in engineering systems is a critical challenge within the scope of Prognostics and Health Management (PHM). The fault diagnosis of complex nonlinear systems, such as hydraulic systems, has become increasingly important due to advancements in big data analytics, machine learning (ML), Industry 4.0, and Internet of Things (IoT) applications.
View Article and Find Full Text PDFNavigating Recent Changes in Dosing Information: Dynamics of FDA-Approved Monoclonal Antibodies in Post-Marketing Realities.
Clin Transl Sci
January 2025
College of Pharmacy, Daegu Catholic University, Gyeongsan, Korea.
Monoclonal antibodies (mAbs) are critical components in the therapeutic landscape, but their dosing strategies often evolve post-approval as new data emerge. This review evaluates post-marketing label changes in dosing information for FDA-approved mAbs from January 2015 to September 2024, with a focus on both initial and extended indications. We systematically analyzed dosing modifications, categorizing them into six predefined groups: Dose increases or decreases, inclusion of new patient populations by body weight or age, shifts from body weight-based dosing to fixed regimens, and adjustments in infusion rates.
View Article and Find Full Text PDFA phase II double-blind multicentre, placebo-controlled trial to assess the efficacy and safety of alpelisib (BYL719) in paediatric and adult patients with Megalencephaly-CApillary malformation Polymicrogyria syndrome (MCAP): the SESAM study protocol.
BMJ Open
December 2024
INSERM UMR1231 Génétique des Anomalies du Développement (GAD), Université de Bourgogne, Dijon, France.
Introduction: The megalencephaly capillary malformation polymicrogyria (MCAP syndrome) results from mosaic gain-of-function variants. The main clinical features are macrocephaly, somatic overgrowth, neurodevelopmental delay and brain anomalies. Alpelisib (Vijoice) is a recently FDA-approved PI3Kα-specific inhibitor for patients with PIK3CA-related overgrowth spectrum (PROS).
View Article and Find Full Text PDFPrevious analyses provide an industry benchmark of ∼10% for the success rate in clinical development. However, prior analyses were limited by a narrow timeframe, a diverse research focus, biases in phase-to-phase transition methodology or a focus on specific use cases. We calculated unbiased input:output ratios (Phase I to FDA new drug approval) to analyze the likelihood of first approval using data from clinicaltrials.
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