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Navigating 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 better understanding of knowledge, attitude and practices of undergraduate medical students towards antimicrobial resistance (AMR) is necessary to identify gaps in the current training curriculum. A 20-point Likert scale-based questionnaire divided into three parts, knowledge, attitude and practices, relating to antibiotic use and resistance was devised. Students attending each year of the undergraduate medical programme were approached to participate in the study over a 1-week period.
View Article and Find Full Text PDFNanoengineered mitochondria enable ocular mitochondrial disease therapy the replacement of dysfunctional mitochondria.
Acta Pharm Sin B
December 2024
State Key Laboratory of Natural Medicines, China Pharmaceutical University, Nanjing 210009, China.
Leber's hereditary optic neuropathy (LHON) is an ocular mitochondrial disease that involves the impairment of mitochondrial complex I, which is an important contributor to blindness among young adults across the globe. However, the disorder has no available cures, since the approved drug idebenone for LHON in Europe relies on bypassing complex I defects rather than fixing them. Herein, mRNA-loaded nanoparticle (mNP)-engineered mitochondria (mNP-Mito) were designed to replace dysfunctional mitochondria with the delivery of exogenous mitochondria, normalizing the function of complex I for treating LHON.
View Article and Find Full Text PDFCardiotoxicity evaluation of two-drug fixed-dose combination therapy under CiPA: a computational study.
Transl Clin Pharmacol
December 2024
Computational Medicine Lab, Department of IT Convergence Engineering, Kumoh National Institute of Technology, Gumi 39177, Korea.
The Comprehensive Proarrhythmia Assay (CiPA) evaluates drug-induced torsade de pointes (TdP) risk, with qNet commonly used to classify drugs into low-, intermediate-, and high-risk categories. While most studies focus on single-drug effects, 2-drug fixed-dose combination (FDC) therapy is widely used for cardiovascular disease management. We aimed to develop the CiPA-based methodology to predict adverse effects of FDC therapy.
View Article and Find Full Text PDFPhase 3, Randomized, Comparison Study of Intracameral Bimatoprost Implant 10 µg and Selective Laser Trabeculoplasty.
Am J Ophthalmol
January 2025
Piedmont Eye Center, Lynchburg, Virginia.
Purpose: To evaluate the intraocular pressure (IOP)-lowering effect and safety of up to two bimatoprost implant administrations versus selective laser trabeculoplasty (SLT).
Design: Phase 3 (Stage 2), randomized, 24-month, multicenter, patient- and efficacy evaluator-masked, paired-eye clinical trial (NCT02507687).
Participants: Patients (n=183) with open-angle glaucoma or ocular hypertension inadequately managed with topical IOP-lowering medication for reasons other than efficacy.
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