Surfactants, Nanomedicines and Nanocarriers: A Critical Evaluation on Clinical Trials
Advances, perspectives and innovation in drug delivery have increased in recent years; however, there is limited information available regarding the actual presence of surfactants, nanomedicines and nanocarriers in investigational medicinal products submitted as part of a request for authorization o...
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2021-03-01
|
| Series: | Pharmaceutics |
| Subjects: | |
| Online Access: | https://www.mdpi.com/1999-4923/13/3/381 |
| _version_ | 1797541488218865664 |
|---|---|
| author | Diego Alejandro Dri Carlotta Marianecci Maria Carafa Elisa Gaucci Donatella Gramaglia |
| author_facet | Diego Alejandro Dri Carlotta Marianecci Maria Carafa Elisa Gaucci Donatella Gramaglia |
| author_sort | Diego Alejandro Dri |
| collection | DOAJ |
| description | Advances, perspectives and innovation in drug delivery have increased in recent years; however, there is limited information available regarding the actual presence of surfactants, nanomedicines 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. |
| first_indexed | 2024-03-10T13:16:45Z |
| format | Article |
| id | doaj.art-b7e8f13dead0461aa9d79b44b23194f0 |
| institution | Directory Open Access Journal |
| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-03-10T13:16:45Z |
| publishDate | 2021-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj.art-b7e8f13dead0461aa9d79b44b23194f02023-11-21T10:21:11ZengMDPI AGPharmaceutics1999-49232021-03-0113338110.3390/pharmaceutics13030381Surfactants, Nanomedicines and Nanocarriers: A Critical Evaluation on Clinical TrialsDiego Alejandro Dri0Carlotta Marianecci1Maria Carafa2Elisa Gaucci3Donatella Gramaglia4Clinical Trials Office, Italian Medicines Agency (AIFA), Via del Tritone 181, 00187 Rome, ItalyDepartment of Chemistry and Technology of Drugs (DCTF), University of Rome “La Sapienza”, Piazzale Aldo Moro 5, 00185 Rome, ItalyDepartment of Chemistry and Technology of Drugs (DCTF), University of Rome “La Sapienza”, Piazzale Aldo Moro 5, 00185 Rome, ItalyClinical Trials Office, Italian Medicines Agency (AIFA), Via del Tritone 181, 00187 Rome, ItalyClinical Trials Office, Italian Medicines Agency (AIFA), Via del Tritone 181, 00187 Rome, ItalyAdvances, perspectives and innovation in drug delivery have increased in recent years; however, there is limited information available regarding the actual presence of surfactants, nanomedicines 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.https://www.mdpi.com/1999-4923/13/3/381clinical trialsnanomedicinesnanocarriersregulatorysurfactants |
| spellingShingle | Diego Alejandro Dri Carlotta Marianecci Maria Carafa Elisa Gaucci Donatella Gramaglia Surfactants, Nanomedicines and Nanocarriers: A Critical Evaluation on Clinical Trials Pharmaceutics clinical trials nanomedicines nanocarriers regulatory surfactants |
| title | Surfactants, Nanomedicines and Nanocarriers: A Critical Evaluation on Clinical Trials |
| title_full | Surfactants, Nanomedicines and Nanocarriers: A Critical Evaluation on Clinical Trials |
| title_fullStr | Surfactants, Nanomedicines and Nanocarriers: A Critical Evaluation on Clinical Trials |
| title_full_unstemmed | Surfactants, Nanomedicines and Nanocarriers: A Critical Evaluation on Clinical Trials |
| title_short | Surfactants, Nanomedicines and Nanocarriers: A Critical Evaluation on Clinical Trials |
| title_sort | surfactants nanomedicines and nanocarriers a critical evaluation on clinical trials |
| topic | clinical trials nanomedicines nanocarriers regulatory surfactants |
| url | https://www.mdpi.com/1999-4923/13/3/381 |
| work_keys_str_mv | AT diegoalejandrodri surfactantsnanomedicinesandnanocarriersacriticalevaluationonclinicaltrials AT carlottamarianecci surfactantsnanomedicinesandnanocarriersacriticalevaluationonclinicaltrials AT mariacarafa surfactantsnanomedicinesandnanocarriersacriticalevaluationonclinicaltrials AT elisagaucci surfactantsnanomedicinesandnanocarriersacriticalevaluationonclinicaltrials AT donatellagramaglia surfactantsnanomedicinesandnanocarriersacriticalevaluationonclinicaltrials |