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AuthorSingh, Ajay Vikram
AuthorBhardwaj, Preeti
AuthorUpadhyay, Aditya Kumar
AuthorPagani, Anselmo
AuthorUpadhyay, Jyoti
AuthorBhadra, Jolly
AuthorTisato, Veronica
AuthorThakur, Manali
AuthorGemmati, Donato
AuthorMishra, Rudresh
AuthorZamboni, Paolo
Available date2024-05-14T09:05:30Z
Publication Date2024-04-25
Publication NameExploration of BioMat-X
Identifierhttp://dx.doi.org/10.37349/ebmx.2024.00009
CitationSingh AV, Bhardwaj P, Upadhyay AK, Pagani A, Upadhyay J, Bhadra J, et al. Navigating regulatory challenges in molecularly tailored nanomedicine. Explor BioMat-X. 2024;1:124–34. https://doi.org/10.37349/ebmx.2024.00009
URIhttp://hdl.handle.net/10576/54982
AbstractNanomedicine, a convergence of nanotechnology and medical sciences, has unleashed transformative potential in healthcare. However, harnessing the benefits of nanomedicine requires a thorough understanding of its regulatory landscape. An in-depth discussion of regulatory considerations, including molecular safety assessment, harmonization of the regulatory landscape, and shaping the future of innovation, is presented in this discourse. The molecular safety assessment entails evaluating interactions between nanoparticles and biomolecules, ensuring compatibility at the molecular level. Harmonization involves developing international standards and guidelines for a consistent regulatory approach, while shaping innovations emphasizes integrating molecular safety assessments into early stages of development. Challenges encompass the need for standardized assessment methods, balancing innovation with safety, and addressing unique features of novel molecular designs. As the nanomedicine landscape evolves, effective regulatory strategies must navigate the intricate interplay of molecules and technologies, ensuring both patient access and product safety.
SponsorThis study was funded by the application of multivalent biomineralized nanostructures as a modular strategy for targeting colorectal cancer [CDIRCC-2024-468] by Qatar University. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Languageen
PublisherOpen Exploration
SubjectNanomedicine
regulatory considerations
molecular safety assessment ,
harmonization
innovations
patient safety
TitleNavigating regulatory challenges in molecularly tailored nanomedicine
TypeArticle
Pagination124-134
Issue Number2
Issue Number1
ESSN2996-9476
dc.accessType Open Access


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