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Cytokine Dynamics in Action: A Mechanistic Approach to Assess Interleukin 6 Related Therapeutic Protein-Drug-Disease Interactions.
Clin Pharmacol Ther
January 2025
Certara Predictive Technologies Division, Certara UK Limited, Sheffield, UK.
Understanding cytokine-related therapeutic protein-drug interactions (TP-DI) is crucial for effective medication management in conditions characterized by elevated inflammatory responses. Recent FDA and ICH guidelines highlight a systematic, risk-based approach for evaluating these interactions, emphasizing the need for a thorough mechanistic understanding of TP-DIs. This study integrates the physiologically based pharmacokinetic (PBPK) model for TP (specifically interleukin-6, IL-6) with small-molecule drug PBPK models to elucidate cytokine-related TP-DI mechanistically.
View Article and Find Full Text PDFThe Safety of Multiple-Dose Liquid Blend Containing Kava and Kratom in Healthy Adults.
Cureus
December 2024
Clinical Pharmacology, Botanic Tonics, LLC, Calabasas, USA.
This study investigates the safety of three different daily dosages of a liquid blend containing kava and kratom (Feel Free® Classic Tonic {FFCT}) in healthy adults over six consecutive days of supplementation. Both kava and kratom have been used traditionally for hundreds of years, but there is limited data on the combined safety of these ingredients. In this randomized, double-blind, placebo-controlled trial, the participants were assigned to receive one of three daily dosages of FFCT or placebo.
View Article and Find Full Text PDFDisparities in response to mRNA SARS-CoV-2 vaccines according to sex and age: A systematic review.
New Microbes New Infect
February 2025
Department of Global and Public Health, Epidemiology, Biostatistics and Prevention Institute, WHO Collaborating Centre for Travellers' Health, Centre of Competence for Military Medicine Biology, University of Zürich, Switzerland.
Background: The rapid development and distribution of mRNA COVID-19 vaccines has been essential in containing the SARS-CoV-2 epidemic around the globe. For ongoing and future immunization campaigns globally, there is a need to evaluate the impact of population demographics such as age and sex, on vaccine efficacy and safety.
Methods: This systematic review (PROSPERO ID CRD42023328245) conducted according to PRISMA guidelines evaluates the impact of age and sex on the safety and efficacy of the mRNA COVID-19 vaccinations administrated in 15 studies that were chosen according to strict criteria.
Delays in health care seeking for diarrheal disease and associated factors among caregivers of under five children in health centers of northwest Ethiopia: a mixed-method study.
BMC Public Health
January 2025
College of Medicine and Health Sciences, Arba Minch University, P.O. Box, 21, Arba Minch City, Ethiopia.
Background: Approximately 70% of child deaths due to diarrhea are caused by a lack of timely healthcare. However, there was little evidence of factors associated with delays in seeking health care for patients with diarrheal diseases in the study area. Therefore, this study aimed to investigate delays in seeking healthcare for children with diarrhea and identify associated factors among caregivers in health centers of Northwest Ethiopia.
View Article and Find Full Text PDFReturn to sports after pediatric traumatic brain injury: An expert panel survey.
PM R
January 2025
Division of Epidemiology, Department of Internal Medicine, University of Utah, Salt Lake City, Utah, USA.
Background: There are no evidence based guidelines for clinicians to follow in advising pediatric patients with traumatic brain injury (TBI) on return to play (RTP).
Objective: To understand practice patterns of experts in pediatric traumatic brain injury (TBI) in relation to how they assess severity of TBI and guide return to play (RTP) decisions with their patients who sustain complicated mild, moderate, or severe TBI.
Design: Cross-sectional web-based survey.
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