The DOI matches its Crossref record; 167 of the 167 references it cites were found in a registry or an index.
Current hurdles to the translation of nanomedicines from bench to the clinic
Open accessAbstract
The field of nanomedicine has significantly influenced research areas such as drug delivery, diagnostics, theranostics, and regenerative medicine; however, the further development of this field will face significant challenges at the regulatory level if related guidance remains unclear and unconsolidated. This review describes those features and pathways crucial to the clinical translation of nanomedicine and highlights considerations for early-stage product development. These include identifying those critical quality attributes of the drug product essential for activity and safety, appropriate analytical methods (physical, chemical, biological) for characterization, important process parameters, and adequate pre-clinical models. Additional concerns include the evaluation of batch-to-batch consistency and considerations regarding scaling up that will ensure a successful reproducible manufacturing process. Furthermore, we advise close collaboration with regulatory agencies from the early stages of development to assure an aligned position to accelerate the development of future nanomedicines. Graphical abstract
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Cites
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Cited by
Clinical translation of nanomedicines: Challenges, opportunities, and keys
Younis, M. A., Tawfeek, H. M., Abdellatif, A. A. H., Abdel-Aleem, J. A., & Harashima, H. (2022) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2021.114083 · Cited by 462
Biosafety of mesoporous silica nanoparticles; towards clinical translation
Lérida-Viso, A., Estepa-Fernández, A., García-Fernández, A., Martí-Centelles, V., & Martínez-Máñez, R. (2023) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2023.115049 · Cited by 279
Sabit, H., Pawlik, T. M., Radwan, F., Abdel-Hakeem, M., Abdel-Ghany, S., Wadan, A.-H. S., Elzawahri, M., El-Hashash, A., & Arneth, B. (2025) · Molecular Cancer · doi:10.1186/s12943-025-02357-z · Cited by 239
Ultrasmall silica nanoparticles in translational biomedical research: Overview and outlook
Singh, N., Shi, S., & Goel, S. (2023) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2022.114638 · Cited by 35
Clinical translation of nanomedicines for brain diseases: Current challenges and future directions
Wang, G., Wang, N., Xia, X., Ismail, M., & Shi, B. (2026) · Journal of Controlled Release · doi:10.1016/j.jconrel.2025.114426 · Cited by 33
Metadata
- Authors
- Đorđević, S., Gonzalez, M. M., Conejos-Sánchez, I., Carreira, B., Pozzi, S., Acúrcio, R. C., Satchi-Fainaro, R., Florindo, H. F., & Vicent, M. J.
- Venue
- Drug Delivery and Translational Research
- Published
- 2021-07-23
- Volume
- 12
- Issue
- 3
- Pages
- 500-525
- ISSN
- 2190-393X (ISSN-L)
- 2190-3948
- OpenAlex
- W3184755963
- Cited by
- 657
- References
- 167
- FWCI
- 10.73
- Type
- journal article
- Language
- en
- Open access
- hybrid
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