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Stability considerations for drug-device combination products-21 CFR part 4 update
Combination products are therapeutic and diagnostic products that include two or more of the following: drug, biologic, and device. These products are needed for enhanced clinical outcomes and have more than one Mode of Action (MOA).
Christopher Latoz +2 more
doaj +1 more source
ABSTRACT Background Parents of children treated for acute lymphoblastic leukemia (ALL) often experience significant caregiver burden and disruption to their well‐being. While parent quality of life (QoL) during treatment is well characterized, little is known about outcomes during early survivorship.
Sara Dal Pra +3 more
wiley +1 more source
Comparison of Generic and Proprietary Sodium Stibogluconate for the Treatment of Visceral Leishmaniasis in Kenya. [PDF]
OBJECTIVE: To compare the use of generic and proprietary sodium stibogluconate for the treatment of visceral leishmaniasis (kala-azar). METHODS: A total of 102 patients with confirmed kala-azar were treated in a mission hospital in West Pokot region ...
Davidson, R N +6 more
core +1 more source
Mediation Analysis Supports a Causal Relationship between Maternal Hyperglycemia and Placental DNA Methylation Variations at the Leptin Gene Locus and Cord Blood Leptin Levels. [PDF]
Changes in fetal DNA methylation (DNAm) of the leptin (LEP) gene have been associated with exposure to maternal hyperglycemia, but their links with childhood obesity risk are still unclear.
Bouchard, Luigi +8 more
core +1 more source
ABSTRACT A second allogeneic (allo‐)hematopoietic stem cell transplantation (HSCT2) is a potential curative option for pediatric patients with acute lymphoblastic leukemia (ALL) following relapse after first allogeneic transplantation (HSCT1), but its efficacy is limited by high relapse rates and transplant‐related toxicity in highly pretreated ...
Ava Momm +10 more
wiley +1 more source
ABSTRACT Introduction Adult‐onset Still's disease (AOSD) complicated by macrophage activation syndrome (MAS) carries substantial mortality. The role of therapeutic plasma exchange (TPE) remains uncertain. Methods We retrospectively analyzed patients with AOSD‐MAS treated with TPE at a single‐center.
Masataka Ueda +15 more
wiley +1 more source
Cosmic Shear Analysis with CFHTLS Deep data
We present the first cosmic shear measurements obtained from the T0001 release of the Canada-France-Hawaii Telescope Legacy Survey. The data set covers three uncorrelated patches (D1, D3 and D4) of one square degree each observed in u*, g', r', i' and z'
Bacon +60 more
core +2 more sources
No-Reference Quality Assessment of Dermoscopic Images Using Minimal Expert Supervision
Background: Assessing image quality is critical in medical imaging to ensure diagnostic reliability. Traditional no-reference image quality assessment (IQA) metrics designed for natural images often fail to address the complexities of medical images ...
Andrea Ferraris +6 more
doaj +1 more source
Reciprocal control of viral infection and phosphoinositide dynamics
Phosphoinositides, although scarce, regulate key cellular processes, including membrane dynamics and signaling. Viruses exploit these lipids to support their entry, replication, assembly, and egress. The central role of phosphoinositides in infection highlights phosphoinositide metabolism as a promising antiviral target.
Marie Déborah Bancilhon, Bruno Mesmin
wiley +1 more source
PCAOB Quality Control Inspections: Unresolved Issues of Registered Firms [PDF]
The Public Company Accounting Oversight Board (PCAOB) has oversight responsibilities that include inspection of not only the audit of financial statements, but also of internal controls and quality controls. The topic of this paper, however, relates only
Newman, Bernard H., Oliverio, Mary Ellen
core +1 more source

