Platform Technology in Global Vaccine Regulation: Development, Applications, and Regulatory Strategies with Insights from China DOI Creative Commons
Xiaojing Li, Jin Su,

Shuyang Guo

et al.

Vaccines, Journal Year: 2024, Volume and Issue: 12(12), P. 1436 - 1436

Published: Dec. 20, 2024

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 COVID-19 pandemic, where platform technology enabled rapid development approval vaccines, optimizing processes, enhancing global public health responses. As a transformative tool, streamlines product development, allowing for reduction in number clinical trials or exemption from certain facilitating cross-referencing submissions. Despite significant efforts establish standardized procedures, challenges remain, particularly achieving unified definition application across regions. This paper explores evolution, applications, strategies technology, with focus on China's experience this field. approach, encompassing risk assessment, expedited emergency offers valuable insights into coordination. By analyzing contributions practices, highlights potential address future pandemics, including "Pathogen X", underscores importance harmonizing strengthen preparedness response.

Language: Английский

Recent Advancements in Gallic Acid-Based Drug Delivery: Applications, Clinical Trials, and Future Directions DOI Creative Commons
Ranjit K. Harwansh, Rohitas Deshmukh,

V Shukla

et al.

Pharmaceutics, Journal Year: 2024, Volume and Issue: 16(9), P. 1202 - 1202

Published: Sept. 13, 2024

Gallic acid (GA) is a well-known herbal bioactive compound found in many herbs and foods like tea, wine, cashew nuts, hazelnuts, walnuts, plums, grapes, mangoes, blackberries, blueberries, strawberries. GA has been reported for several pharmacological activities, such as antioxidant, inflammatory, antineoplastic, antimicrobial, etc. Apart from its incredible therapeutic benefits, it associated with low permeability bioavailability issues, limiting their efficacy. belongs to BCS (Biopharmaceutics classification system) class III (high solubility probability). In this context, novel drug delivery approaches played vital role resolving these issues. Nanocarrier systems help improve moiety’s physical chemical stability by encapsulating them into lipidic or polymeric matrix core system. regard, researchers have developed wide range of nanocarrier GA, including liposomes, transfersomes, niosomes, dendrimers, phytosomes, micelles, nanoemulsions, metallic nanoparticles, solid lipid nanoparticles (SLNs), nanostructured carriers, polymer conjugates, the present review, different search engines Scopus, PubMed, ScienceDirect, Google Scholar referred acquiring recent information on theme work. Therefore, review paper aims emphasize systems, patents, clinical updates GA.

Language: Английский

Citations

6
Bioanalytical Assays for Oligonucleotide Therapeutics: Adding Antibody-Based Immunoassays to the Toolbox as an Orthogonal Approach to LC-MS/MS and Ligand Binding Assays DOI
David P. Chimento, Amy Anderson,

Inês Fial

et al.

Nucleic Acid Therapeutics, Journal Year: 2025, Volume and Issue: 35(1), P. 6 - 15

Published: Feb. 1, 2025

Language: Английский

Citations

0
Platform Technology in Global Vaccine Regulation: Development, Applications, and Regulatory Strategies with Insights from China DOI Creative Commons
Xiaojing Li, Jin Su,

Shuyang Guo

et al.

Vaccines, Journal Year: 2024, Volume and Issue: 12(12), P. 1436 - 1436

Published: Dec. 20, 2024

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 COVID-19 pandemic, where platform technology enabled rapid development approval vaccines, optimizing processes, enhancing global public health responses. As a transformative tool, streamlines product development, allowing for reduction in number clinical trials or exemption from certain facilitating cross-referencing submissions. Despite significant efforts establish standardized procedures, challenges remain, particularly achieving unified definition application across regions. This paper explores evolution, applications, strategies technology, with focus on China's experience this field. approach, encompassing risk assessment, expedited emergency offers valuable insights into coordination. By analyzing contributions practices, highlights potential address future pandemics, including "Pathogen X", underscores importance harmonizing strengthen preparedness response.

Language: Английский

Citations

0