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Current hurdles to the translation of nanomedicines from bench to the clinic

Đorđević, Snežana ; Gonzalez, María Medel ; Conejos-Sánchez, Inmaculada ; Carreira, Barbara ; Pozzi, Sabina ; Acúrcio, Rita C. ; Satchi-Fainaro, Ronit ; Florindo, Helena F. ; Vicent, María J.

Drug delivery and translational research, 2022-03, Vol.12 (3), p.500-525 [Periódico revisado por pares]

New York: Springer US

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Título:
Current hurdles to the translation of nanomedicines from bench to the clinic
Autor: Đorđević, Snežana ; Gonzalez, María Medel ; Conejos-Sánchez, Inmaculada ; Carreira, Barbara ; Pozzi, Sabina ; Acúrcio, Rita C. ; Satchi-Fainaro, Ronit ; Florindo, Helena F. ; Vicent, María J.
Assuntos: Biomedical and Life Sciences ; Biomedicine ; Drug Delivery Systems ; Nanomedicine - methods ; Pharmaceutical Preparations ; Pharmaceutical Sciences/Technology ; Regenerative Medicine ; Research Design ; Review ; Review Article
É parte de: Drug delivery and translational research, 2022-03, Vol.12 (3), p.500-525
Descrição: 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
Editor: New York: Springer US
Idioma: Inglês

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Current hurdles to the translation of nanomedicines from bench to the clinic

Đorđević, Snežana ; Gonzalez, María Medel ; Conejos-Sánchez, Inmaculada ; Carreira, Barbara ; Pozzi, Sabina ; Acúrcio, Rita C. ; Satchi-Fainaro, Ronit ; Florindo, Helena F. ; Vicent, María J.

New York: Springer US

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