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Nasal absorption of oxycodone predicted using a novel computational fluid dynamics-physiologically based pharmacokinetic model.
J Control Release
December 2024
Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Oxycodone hydrochloride (HCl) extended release (ER) tablet is an abuse-deterrent formulation that uses a physical barrier to make it more difficult to crush tablets prior to abuse via various routes. A previously conducted in vivo pharmacokinetics (PK) study showed that particle size exhibited significant effects on PK. Here, a computational modeling study using a novel combined computational fluid dynamics and physiologically based PK model was applied to better understand the mechanisms that produce differences in PK according to particle size and formulation type for nasally insufflated oxycodone HCl immediate release (IR) and ER ts.
View Article and Find Full Text PDFCell-Based Assays to Detect Innate Immune Response Modulating Impurities: Application to Biosimilar Insulin.
AAPS J
December 2024
Laboratory of Immunology, Office of Pharmaceutical Quality Research Division-IV, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA.
Characterizing and mitigating factors that impact product immunogenicity can aid in risk assessment and/or managing risk following manufacturing changes. For follow-on products that have the same indication, patient population, and active product ingredient, the residual immunogenicity risk resides predominantly on differences in product and process related impurities. Characterizing differences in innate immune modulating impurities (IIRMI), which could act as adjuvants by activating local antigen presenting cells (APCs), can inform the immunogenicity risk assessment potentially reducing the need for clinical trials.
View Article and Find Full Text PDFNational Survey of Airway Management Practices and Training Among Emergency Medicine Residency Programs in the United States.
Perm J
December 2024
Department of Emergency Medicine, Kaiser Permanente San Diego Medical Center, San Diego, CA, USA.
Article Synopsis
- A study was conducted to analyze airway management training in emergency medicine residency programs across the U.S., highlighting the need for residents to receive extensive training due to evolving practices.
- The study surveyed 258 residency program directors, with 63 responding, primarily from university-based hospitals, revealing that residents typically perform 50-100 intubations, but few pediatric intubations.
- The results indicate a rising use of video laryngoscopy and varied teaching methods to enhance resident exposure to advanced airway management techniques in emergency medicine.
Teaching the New Ways: Improving Resident Documentation for the New 2023 Coding Requirements.
West J Emerg Med
November 2024
University of Vermont Medical Center, Burlington, Vermont.
Effectiveness of the upscaled use of a silver-ceramic (silver ionization) technology to disinfect drinking water in tanks at schools in rural India.
J Water Health
November 2024
S M Sehgal Foundation, Plot 34, Sector 44, Institutional Area, Gurugram, Haryana 122003, India.
In many low- and middle-income countries, school children consume untreated water that has been pumped into storage tanks. The water is often of poor quality and consumption can cause gastrointestinal illnesses resulting in missed school days, growth stunting, and cognitive impairment. This study deployed a silver-ceramic technology (MadiDrop) to disinfect drinking water in school storage tanks.
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