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Medicine availability and affordability for paediatric cancers, China.
Bull World Health Organ
January 2025
Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, 38 Xueyuan Road, Haidian District, Beijing, 100191, China.
Objective: To investigate access to essential anticancer medicines for children throughout China.
Methods: We obtained cross-sectional drug use data for 2021 from 55 tertiary children's hospitals in seven geographical regions (one third of public children's hospitals in mainland China). Affordability was assessed by comparing the single-day copayment for each medicine with the same generic name and route of administration (i.
Investigation of the Thermal Stability and Hydrolytic Degradation Kinetics of Poly(Lactide-co-Glycolide) Melts.
AAPS PharmSciTech
January 2025
Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, The University of Texas at Austin, Austin, Texas, USA.
Poly(lactide-co-glycolide) (PLGA) is widely used in a variety of long-acting injectables. However, its biodegradable nature creates potential chemical stability challenges during melt extrusion, where PLGA is exposed to elevated temperature (100-140 °C) for several minutes. This study evaluated the thermal stability of three PLGA grades (Resomer® 502, 502H, and 505) with varying molecular weights and chain-ends using a differential scanning calorimeter and twin-screw extruder.
View Article and Find Full Text PDFValidation of a liquid chromatography-high-resolution mass spectrometry method to quantify peptide-related impurities in teriparatide.
J Pharm Biomed Anal
December 2024
Office of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, St. Louis, MO 63110, USA.
With recent advances in quantitative high-resolution mass spectrometry (HRMS), there is growing interest in developing liquid chromatography (LC)-HRMS methods that can simultaneously quantify numerous critical impurities in a peptide or protein drug. This approach is attractive as it could reduce the total number of methods and instruments required during product development and quality control testing, while taking advantage of the technique's high specificity and sensitivity. To investigate the feasibility of this approach for peptide drugs, an LC-HRMS method was validated for the quantification of six peptide-related impurities in teriparatide, the 34-amino acid active ingredient in Forteo.
View Article and Find Full Text PDFBackground And Objectives: Generic formulations of glatiramer acetate have been available since 2015 yet remain underprescribed relative to the branded product. We sought to characterize the association between branded glatiramer prescribing in the Medicare program and financial payments from the manufacturer (Teva Pharmaceuticals).
Methods: Using publicly available Medicare Part D and Open Payments data from the Centers for Medicare and Medicaid Services, we evaluated overall utilization from 2012 to 2021 and compared the prevalence, frequency, and magnitude of financial payments made in 2019 to neurologists who prescribed branded and generic versions of glatiramer in 2020.
Unveiling the Potential of C Factor Applied to Pilot Bioavailability/Bioequivalence Studies-A Case Study with Pazopanib Drug Products.
Pharmaceutics
December 2024
Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, 1649-003 Lisbon, Portugal.
When companies are uncertain about the potential of a new formulation to be bioequivalent to a Reference product, it is common practice to carry out downsized pilot studies as a gatekeeping in vivo strategy to decide whether to move forward or not with a full-size pivotal study. However, due to the small study size, these studies are inarguably more sensitive to variability. To address and mitigate the uncertainty of the conclusions of pilot studies concerning the maximum observed concentration (C), the factor was proposed as an alternative approach to the average bioequivalence statistical methodology.
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