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Platform Technology in Global Vaccine Regulation: Development, Applications, and Regulatory Strategies with Insights from China.
Vaccines (Basel)
December 2024
Center for Drug Evaluation, National Medical Products Administration, Zone 2, No. 22 Guangde Street, Beijing Economic and Technological Development Zone, Beijing 100076, China.
The concept of "platform technology" gained prominence after the Ebola outbreak and since then has become essential to international vaccine (prophylactic vaccines against infectious disease) regulatory frameworks. Its significance was further amplified during the COVID-19 pandemic, where platform technology enabled the rapid development and approval of vaccines, optimizing regulatory processes, and enhancing global public health responses. As a transformative tool, platform technology streamlines product development, allowing for the reduction in the number of clinical trials or exemption from certain clinical trials and facilitating cross-referencing in regulatory submissions.
View Article and Find Full Text PDFExploring Technology Acceptance of Healthcare Devices: The Moderating Role of Device Type and Generation.
Sensors (Basel)
December 2024
School of Hospitality & Tourism Management, Kyungsung University, Busan 48434, Republic of Korea.
The increasing adoption of healthcare devices necessitates a deeper understanding of the factors that influence user acceptance in this rapidly evolving area. Therefore, this study examined the factors influencing the technology acceptance of healthcare devices, focusing on radar sensors and wearable devices. A total of 1158 valid responses were used to test hypotheses, mediation, and moderation effects using SmartPLS 4.
View Article and Find Full Text PDFRandomized Clinical Evaluation of the Healing Activity of Green Propolis Ointment in Individuals with Lower Limb Ulcers Resulting from Leprosy: Preliminary Results of a Pilot Study.
Pharmaceuticals (Basel)
December 2024
Laboratory of Molecular Pharmacology and Bioactive Compounds, Postgraduate Program in Health Sciences, São Francisco University, 215 São Francisco de Assis Avenue, Bragança Paulista 12916-900, São Paulo, Brazil.
Treating chronic wounds incurs substantial costs for Brazil's Unified Health System. Natural compounds, particularly propolis, are increasingly explored as low-cost alternatives due to their healing properties. Brazilian green propolis, distinct in its chemical composition, has garnered scientific interest.
View Article and Find Full Text PDFN-methyl-D-aspartate Receptors and Depression: Linking Psychopharmacology, Pathology and Physiology in a Unifying Hypothesis for the Epigenetic Code of Neural Plasticity.
Pharmaceuticals (Basel)
November 2024
Relmada Therapeutics, Inc., Coral Gables, FL 33134, USA.
Uncompetitive NMDAR (N-methyl-D-aspartate receptor) antagonists restore impaired neural plasticity, reverse depressive-like behavior in animal models, and relieve major depressive disorder (MDD) in humans. This review integrates recent findings from in silico, in vitro, in vivo, and human studies of uncompetitive NMDAR antagonists into the extensive body of knowledge on NMDARs and neural plasticity. Uncompetitive NMDAR antagonists are activity-dependent channel blockers that preferentially target hyperactive GluN2D subtypes because these subtypes are most sensitive to activation by low concentrations of extracellular glutamate and are more likely activated by certain pathological agonists and allosteric modulators.
View Article and Find Full Text PDFVaccination Schedule and Age Influence Impaired Responsiveness to Hepatitis B Vaccination: A Randomized Trial in Central Asia.
Pathogens
December 2024
Research Group Biomarkers for Infectious Diseases, TWINCORE Centre for Experimental and Clinical Infection Research, 30625 Hannover, Germany.
Vaccination against hepatitis B virus (HBV) is the most cost-efficient measure to prevent infection. Still, vaccination coverage among adults in Central Asia, including Kyrgyzstan, remains suboptimal, and data about immune responses to HBV vaccination are lacking. HBV vaccination is given as three injections, whereby the second and third doses are given 1 and 6 months after the first (0-1-6 scheme).
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