Critical Analysis and Quality Assessment of Nanomedicines and Nanocarriers in Clinical Trials: Three Years of Activity at the Clinical Trials Office
Investigational medicinal products submitted over the course of 3 years and authorized at the Clinical Trials Office of the Italian Medicines Agency as part of a request for authorization of clinical trials were scrutinized to identify those encompassing nanomedicines. The quality assessment reports...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-07-01
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| Series: | Pharmaceutics |
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| Online Access: | https://www.mdpi.com/1999-4923/14/7/1438 |
| _version_ | 1797433195654807552 |
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| author | Diego Alejandro Dri Elisa Gaucci Ilaria Torrieri Maria Carafa Carlotta Marianecci Donatella Gramaglia |
| author_facet | Diego Alejandro Dri Elisa Gaucci Ilaria Torrieri Maria Carafa Carlotta Marianecci Donatella Gramaglia |
| author_sort | Diego Alejandro Dri |
| collection | DOAJ |
| description | Investigational medicinal products submitted over the course of 3 years and authorized at the Clinical Trials Office of the Italian Medicines Agency as part of a request for authorization of clinical trials were scrutinized to identify those encompassing nanomedicines. The quality assessment reports performed on the documentation submitted were analyzed, classifying and discussing the most frequently detected issues. The identification of nanomedicines retrieved and the information on their quality profiles are shared to increase the transparency and availability of information, providing feedback that can support sponsors in optimizing the quality part of the documentation and of the information submitted. Results confirm that nanomedicines tested as investigational medicinal products in clinical trials are developed and authorized in agreement with the highest standards of quality, meeting safety profiles according to the strong regulatory requirements in the European Union. Some key points are highlighted and indicate that the regulatory approach to innovation in a clinical trial setting could potentially be renewed to ride the wave of innovation, particularly in the nanotechnology field, capitalizing on lessons learned and still ensuring a strong and effective framework. |
| first_indexed | 2024-03-09T10:13:35Z |
| format | Article |
| id | doaj.art-8e68d0777d2d42edab49df9b6adecefb |
| institution | Directory Open Access Journal |
| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-03-09T10:13:35Z |
| publishDate | 2022-07-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj.art-8e68d0777d2d42edab49df9b6adecefb2023-12-01T22:34:40ZengMDPI AGPharmaceutics1999-49232022-07-01147143810.3390/pharmaceutics14071438Critical Analysis and Quality Assessment of Nanomedicines and Nanocarriers in Clinical Trials: Three Years of Activity at the Clinical Trials OfficeDiego Alejandro Dri0Elisa Gaucci1Ilaria Torrieri2Maria Carafa3Carlotta Marianecci4Donatella Gramaglia5Clinical 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, ItalyDepartment Drug Chemistry and Technologies (DCTF), Sapienza, University of Rome, Piazzale Aldo Moro 5, 00185 Rome, ItalyDepartment Drug Chemistry and Technologies (DCTF), Sapienza, University of Rome, Piazzale Aldo Moro 5, 00185 Rome, ItalyDepartment Drug Chemistry and Technologies (DCTF), Sapienza, University of Rome, Piazzale Aldo Moro 5, 00185 Rome, ItalyClinical Trials Office, Italian Medicines Agency (AIFA), Via del Tritone 181, 00187 Rome, ItalyInvestigational medicinal products submitted over the course of 3 years and authorized at the Clinical Trials Office of the Italian Medicines Agency as part of a request for authorization of clinical trials were scrutinized to identify those encompassing nanomedicines. The quality assessment reports performed on the documentation submitted were analyzed, classifying and discussing the most frequently detected issues. The identification of nanomedicines retrieved and the information on their quality profiles are shared to increase the transparency and availability of information, providing feedback that can support sponsors in optimizing the quality part of the documentation and of the information submitted. Results confirm that nanomedicines tested as investigational medicinal products in clinical trials are developed and authorized in agreement with the highest standards of quality, meeting safety profiles according to the strong regulatory requirements in the European Union. Some key points are highlighted and indicate that the regulatory approach to innovation in a clinical trial setting could potentially be renewed to ride the wave of innovation, particularly in the nanotechnology field, capitalizing on lessons learned and still ensuring a strong and effective framework.https://www.mdpi.com/1999-4923/14/7/1438clinical trialsinvestigational medicinal productsnanocarriernanomedicinequalityregulatory |
| spellingShingle | Diego Alejandro Dri Elisa Gaucci Ilaria Torrieri Maria Carafa Carlotta Marianecci Donatella Gramaglia Critical Analysis and Quality Assessment of Nanomedicines and Nanocarriers in Clinical Trials: Three Years of Activity at the Clinical Trials Office Pharmaceutics clinical trials investigational medicinal products nanocarrier nanomedicine quality regulatory |
| title | Critical Analysis and Quality Assessment of Nanomedicines and Nanocarriers in Clinical Trials: Three Years of Activity at the Clinical Trials Office |
| title_full | Critical Analysis and Quality Assessment of Nanomedicines and Nanocarriers in Clinical Trials: Three Years of Activity at the Clinical Trials Office |
| title_fullStr | Critical Analysis and Quality Assessment of Nanomedicines and Nanocarriers in Clinical Trials: Three Years of Activity at the Clinical Trials Office |
| title_full_unstemmed | Critical Analysis and Quality Assessment of Nanomedicines and Nanocarriers in Clinical Trials: Three Years of Activity at the Clinical Trials Office |
| title_short | Critical Analysis and Quality Assessment of Nanomedicines and Nanocarriers in Clinical Trials: Three Years of Activity at the Clinical Trials Office |
| title_sort | critical analysis and quality assessment of nanomedicines and nanocarriers in clinical trials three years of activity at the clinical trials office |
| topic | clinical trials investigational medicinal products nanocarrier nanomedicine quality regulatory |
| url | https://www.mdpi.com/1999-4923/14/7/1438 |
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