Advances, perspectives and innovation in drug delivery have increased in recent years; however, there is limited information available regarding the actual presence of surfactants, nanomed-icines and nanocarriers in investigational medicinal products submitted as part of a request for authorization of clinical trials, particularly for those authorized in the European Economic Area. We retrieve, analyze and report data available at the Clinical Trial Office of the Italian Medicines Agency (AIFA), increasing the transparency and availability of relevant information. An analysis of quality documentation submitted along with clinical trials authorized by the AIFA in 2018 was carried out, focusing on the key terms “surfactant”, “nanomedicine” and “nanocarrier”. Results suggest potential indications and inputs for further reflection and actions for regulators to actively and safely drive innovation from a regulatory perspective and to transpose upcoming evolution of clinical trials within a strong regulatory framework.

Surfactants, nanomedicines and nanocarriers: a critical evaluation on clinical trials / Dri, D. A.; Marianecci, C.; Carafa, M.; Gaucci, E.; Gramaglia, D.. - In: PHARMACEUTICS. - ISSN 1999-4923. - 13:3(2021). [10.3390/pharmaceutics13030381]

Surfactants, nanomedicines and nanocarriers: a critical evaluation on clinical trials

Dri D. A.
Primo
;
Marianecci C.
;
Carafa M.;Gaucci E.;
2021

Abstract

Advances, perspectives and innovation in drug delivery have increased in recent years; however, there is limited information available regarding the actual presence of surfactants, nanomed-icines and nanocarriers in investigational medicinal products submitted as part of a request for authorization of clinical trials, particularly for those authorized in the European Economic Area. We retrieve, analyze and report data available at the Clinical Trial Office of the Italian Medicines Agency (AIFA), increasing the transparency and availability of relevant information. An analysis of quality documentation submitted along with clinical trials authorized by the AIFA in 2018 was carried out, focusing on the key terms “surfactant”, “nanomedicine” and “nanocarrier”. Results suggest potential indications and inputs for further reflection and actions for regulators to actively and safely drive innovation from a regulatory perspective and to transpose upcoming evolution of clinical trials within a strong regulatory framework.
2021
clinical trials; nanocarriers; nanomedicines; regulatory; surfactants
01 Pubblicazione su rivista::01a Articolo in rivista
Surfactants, nanomedicines and nanocarriers: a critical evaluation on clinical trials / Dri, D. A.; Marianecci, C.; Carafa, M.; Gaucci, E.; Gramaglia, D.. - In: PHARMACEUTICS. - ISSN 1999-4923. - 13:3(2021). [10.3390/pharmaceutics13030381]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1540780
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