Navigating regulatory challenges in molecularly tailored nanomedicine
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 mol...
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| Format: | Article |
| Language: | English |
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Open Exploration Publishing Inc.
2024-04-01
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| Series: | Exploration of BioMat-X |
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| Online Access: | https://www.explorationpub.com/uploads/Article/A10139/10139.pdf |
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| author | Ajay Vikram Singh Preeti Bhardwaj Aditya Kumar Upadhyay Anselmo Pagani Jyoti Upadhyay Jolly Bhadra Veronica Tisato Manali Thakur Donato Gemmati Rudresh Mishra Paolo Zamboni |
| author_facet | Ajay Vikram Singh Preeti Bhardwaj Aditya Kumar Upadhyay Anselmo Pagani Jyoti Upadhyay Jolly Bhadra Veronica Tisato Manali Thakur Donato Gemmati Rudresh Mishra Paolo Zamboni |
| author_sort | Ajay Vikram Singh |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-f584e57f4a304a12bd14d19c1f9075b4 |
| institution | Kabale University |
| issn | 2996-9476 |
| language | English |
| publishDate | 2024-04-01 |
| publisher | Open Exploration Publishing Inc. |
| record_format | Article |
| series | Exploration of BioMat-X |
| spelling | doaj-art-f584e57f4a304a12bd14d19c1f9075b42025-08-20T03:51:19ZengOpen Exploration Publishing Inc.Exploration of BioMat-X2996-94762024-04-011212413410.37349/ebmx.2024.00009Navigating regulatory challenges in molecularly tailored nanomedicineAjay Vikram Singh0https://orcid.org/0000-0002-9875-7727Preeti Bhardwaj1Aditya Kumar Upadhyay2Anselmo Pagani3Jyoti Upadhyay4Jolly Bhadra5https://orcid.org/0000-0002-1350-6153Veronica Tisato6https://orcid.org/0000-0001-8448-066XManali Thakur7Donato Gemmati8https://orcid.org/0000-0001-6213-6120Rudresh Mishra9Paolo Zamboni10https://orcid.org/0000-0002-7107-888XDepartment of Chemical and Product Safety, German Federal Institute of Risk Assessment (BfR), 10589 Berlin, GermanyDepartment of Chemical and Product Safety, German Federal Institute of Risk Assessment (BfR), 10589 Berlin, GermanyInfosys LT, Hinjawadi Rajiv Gandhi Infotech Park, Hinjawadi, Pune 411057, IndiaChair Vascular Diseases Center, University of Ferrara, 44124 Ferrara, ItalyKamla Nehru Institute of Physical and Social Sciences (KNIPSS), Sultanpur 228001, IndiaQatar University Young Research Centre (QUYRC), Qatar University, Doha 2053, QatarDepartment of Translational Medicine, University of Ferrara, 44121 Ferrara, Italy; Centre Haemostasis and Thrombosis, University of Ferrara, 44121 Ferrara, ItalyFaculty of Informatics, Otto von Guericke University, 39106 Magdeburg, GermanyDepartment of Translational Medicine, University of Ferrara, 44121 Ferrara, Italy; Centre Haemostasis and Thrombosis, University of Ferrara, 44121 Ferrara, ItalyPWC Consultants, Rue Gerhard Mercator, 2122 Gesperich, LuxembourgChair Vascular Diseases Center, University of Ferrara, 44124 Ferrara, ItalyNanomedicine, 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.https://www.explorationpub.com/uploads/Article/A10139/10139.pdfnanomedicineregulatory considerationsmolecular safety assessmentharmonizationinnovationspatient safety |
| spellingShingle | Ajay Vikram Singh Preeti Bhardwaj Aditya Kumar Upadhyay Anselmo Pagani Jyoti Upadhyay Jolly Bhadra Veronica Tisato Manali Thakur Donato Gemmati Rudresh Mishra Paolo Zamboni Navigating regulatory challenges in molecularly tailored nanomedicine Exploration of BioMat-X nanomedicine regulatory considerations molecular safety assessment harmonization innovations patient safety |
| title | Navigating regulatory challenges in molecularly tailored nanomedicine |
| title_full | Navigating regulatory challenges in molecularly tailored nanomedicine |
| title_fullStr | Navigating regulatory challenges in molecularly tailored nanomedicine |
| title_full_unstemmed | Navigating regulatory challenges in molecularly tailored nanomedicine |
| title_short | Navigating regulatory challenges in molecularly tailored nanomedicine |
| title_sort | navigating regulatory challenges in molecularly tailored nanomedicine |
| topic | nanomedicine regulatory considerations molecular safety assessment harmonization innovations patient safety |
| url | https://www.explorationpub.com/uploads/Article/A10139/10139.pdf |
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