Navigating regulatory challenges in molecularly tailored nanomedicine
المؤلف | Singh, Ajay Vikram |
المؤلف | Bhardwaj, Preeti |
المؤلف | Upadhyay, Aditya Kumar |
المؤلف | Pagani, Anselmo |
المؤلف | Upadhyay, Jyoti |
المؤلف | Bhadra, Jolly |
المؤلف | Tisato, Veronica |
المؤلف | Thakur, Manali |
المؤلف | Gemmati, Donato |
المؤلف | Mishra, Rudresh |
المؤلف | Zamboni, Paolo |
تاريخ الإتاحة | 2024-05-14T09:05:30Z |
تاريخ النشر | 2024-04-25 |
اسم المنشور | Exploration of BioMat-X |
المعرّف | http://dx.doi.org/10.37349/ebmx.2024.00009 |
الاقتباس | 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 |
الملخص | 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. |
راعي المشروع | 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. |
اللغة | en |
الناشر | Open Exploration |
الموضوع | Nanomedicine regulatory considerations molecular safety assessment , harmonization innovations patient safety |
النوع | Article |
الصفحات | 124-134 |
رقم العدد | 2 |
رقم العدد | 1 |
ESSN | 2996-9476 |
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