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[Drug safety and mandatory reporting].
Schmerz
January 2025
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Deutschland.
The spontaneous reporting system for cases of suspected side effects is a central instrument for detecting possible side effects after a pharmaceutical preparation has received marketing authorization. It provides important information (signals) on the occurrence of rare, previously unknown side effects, on increases in the frequency of known side effects that may also be due to quality defects, or on changes in the type or severity of known side effects. In recent decades, this system has made a significant contribution to the identification of drug-related risks that only arise upon widespread use following approval and to the introduction of appropriate measures to minimize risk.
View Article and Find Full Text PDFAltered Oscillatory Neural Dynamics Related to Word Prediction in Older Adult Readers.
Lang Cogn Neurosci
July 2024
Beckman Institute for Advanced Science and Technology, University of Illinois Urbana-Champaign, USA.
The engagement of predictive mechanisms during language comprehension can facilitate processing and modulate neural oscillatory activity. These modulations include alpha-band activity decreases prior to expected words, reflecting anticipatory preparation, and frontal theta-band activity following unexpected words, reflecting engagement of cognitive control. It remains unknown how these oscillatory dynamics are impacted by aging.
View Article and Find Full Text PDF-Glucan-modified nanoparticles with different particle sizes exhibit different lymphatic targeting efficiencies and adjuvant effects.
J Pharm Anal
December 2024
Department of Pharmaceutics, School of Pharmacy, Shenyang Pharmaceutical University, 103 Wenhua Road, Shenyang, Liaoning Province 110016, China.
Particle size and surface properties are crucial for lymphatic drainage (LN), dendritic cell (DC) uptake, DC maturation, and antigen cross-presentation induced by nanovaccine injection, which lead to an effective cell-mediated immune response. However, the manner in which the particle size and surface properties of vaccine carriers such as mesoporous silica nanoparticles (MSNs) affect this immune response is unknown. We prepared 50, 100, and 200 nm of MSNs that adsorbed ovalbumin antigen (OVA) while modifying -glucan to enhance immunogenicity.
View Article and Find Full Text PDFCreating the 5A Nursing Response Model for the Emerging Pandemic: A Qualitative, Theory-Generating Study.
J Adv Nurs
January 2025
DePaul University, Chicago, Illinois, USA.
Aim: The aim of this qualitative exploratory study aimed was to explore how nurses experienced and responded to the COVID-19 pandemic crisis in clinical settings to develop a response model.
Design: Focus group interviews.
Methods: Thirteen focus group interviews (n = 50) with nurses and nurse leaders practicing in diverse clinical settings were conducted between May and July of 2021 in South Korea.
Operating Characteristics of the Simulated Healthy Participant Approach in Impaired Clearance Studies.
AAPS J
January 2025
Pharmacometrics and Systems Pharmacology, Pfizer, Groton, Connecticut, U.S.A..
Minimizing harm is a cornerstone of ethical research practices. A drug that has undergone extensive clinical pharmacological testing in healthy participants (HPs) and a diverse selection of patients can be described with a sufficiently predictive population pharmacokinetic (PopPK) model. In impaired clearance trials, recruitment is minimized and underpowered for all but major exposure differences.
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