Navigating regulatory challenges in molecularly tailored nanomedicine
Author | Singh, Ajay Vikram |
Author | Bhardwaj, Preeti |
Author | Upadhyay, Aditya Kumar |
Author | Pagani, Anselmo |
Author | Upadhyay, Jyoti |
Author | Bhadra, Jolly |
Author | Tisato, Veronica |
Author | Thakur, Manali |
Author | Gemmati, Donato |
Author | Mishra, Rudresh |
Author | Zamboni, Paolo |
Available date | 2024-05-14T09:05:30Z |
Publication Date | 2024-04-25 |
Publication Name | Exploration of BioMat-X |
Identifier | http://dx.doi.org/10.37349/ebmx.2024.00009 |
Citation | Singh 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 |
Abstract | Nanomedicine, 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. |
Sponsor | This 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. |
Language | en |
Publisher | Open Exploration |
Subject | Nanomedicine regulatory considerations molecular safety assessment , harmonization innovations patient safety |
Type | Article |
Pagination | 124-134 |
Issue Number | 2 |
Issue Number | 1 |
ESSN | 2996-9476 |
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Research of Qatar University Young Scientists Center [202 items ]