Nanopharmaceutics: Part I-Clinical Trials Legislation and Good Manufacturing Practices (GMP) of Nanotherapeutics in the EU
Autor(a) principal: | |
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Data de Publicação: | 2020 |
Outros Autores: | , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | http://hdl.handle.net/10316/106533 https://doi.org/10.3390/pharmaceutics12020146 |
Resumo: | The latest advances in pharmaceutical technology are leading to the development of cutting edged approaches to produce what is now known as the "Holy Grail" of medicine-nanopharmaceutics. Over the latest decade, the pharmaceutical industry has made important contributions to the scale up of these new products. To ensure their quality, efficacy, and safety for human use, clinical trials are mandatory. Yet, regulation regarding nanopharmaceuticals is still limited with a set of guidelines being recently released with respect to compliance with quality and safety. For the coming years, updates on regulatory issues about nanopharmaceuticals and their use in clinical settings are expected. The use of nanopharmaceuticals in clinical trials depends on the approval of the production methods and assurance of the quality of the final product by implementation and verification of the good manufacturing practices (GMP). This review addresses the available legislation on nanopharmaceuticals within the European Union (EU), the GMP that should be followed for their production, and the current challenges encountered in clinical trials of these new formulations. The singular properties of nanopharmaceuticals over their bulk counterparts are associated with their size, matrix composition, and surface properties. To understand their relevance, four main clinical trial guidelines, namely, for intravenous iron-based nanopharmaceuticals, liposomal-based nanopharmaceuticals, block copolymer micelle-based nanopharmaceuticals, and related to surface coating requirements, are described here. |
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Nanopharmaceutics: Part I-Clinical Trials Legislation and Good Manufacturing Practices (GMP) of Nanotherapeutics in the EUnanopharmaceuticslegislationclinical trialsqualitysafetyGMPThe latest advances in pharmaceutical technology are leading to the development of cutting edged approaches to produce what is now known as the "Holy Grail" of medicine-nanopharmaceutics. Over the latest decade, the pharmaceutical industry has made important contributions to the scale up of these new products. To ensure their quality, efficacy, and safety for human use, clinical trials are mandatory. Yet, regulation regarding nanopharmaceuticals is still limited with a set of guidelines being recently released with respect to compliance with quality and safety. For the coming years, updates on regulatory issues about nanopharmaceuticals and their use in clinical settings are expected. The use of nanopharmaceuticals in clinical trials depends on the approval of the production methods and assurance of the quality of the final product by implementation and verification of the good manufacturing practices (GMP). This review addresses the available legislation on nanopharmaceuticals within the European Union (EU), the GMP that should be followed for their production, and the current challenges encountered in clinical trials of these new formulations. The singular properties of nanopharmaceuticals over their bulk counterparts are associated with their size, matrix composition, and surface properties. To understand their relevance, four main clinical trial guidelines, namely, for intravenous iron-based nanopharmaceuticals, liposomal-based nanopharmaceuticals, block copolymer micelle-based nanopharmaceuticals, and related to surface coating requirements, are described here.MDPI2020-02-11info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlehttp://hdl.handle.net/10316/106533http://hdl.handle.net/10316/106533https://doi.org/10.3390/pharmaceutics12020146eng1999-4923Souto, Eliana B.Silva, Gabriela F.Dias-Ferreira, JoãoZielińska, AleksandraVentura, FátimaDurazzo, AlessandraLucarini, MassimoNovellino, EttoreSantini, Antonelloinfo:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-04-10T20:43:15Zoai:estudogeral.uc.pt:10316/106533Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T21:22:58.672865Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
dc.title.none.fl_str_mv |
Nanopharmaceutics: Part I-Clinical Trials Legislation and Good Manufacturing Practices (GMP) of Nanotherapeutics in the EU |
title |
Nanopharmaceutics: Part I-Clinical Trials Legislation and Good Manufacturing Practices (GMP) of Nanotherapeutics in the EU |
spellingShingle |
Nanopharmaceutics: Part I-Clinical Trials Legislation and Good Manufacturing Practices (GMP) of Nanotherapeutics in the EU Souto, Eliana B. nanopharmaceutics legislation clinical trials quality safety GMP |
title_short |
Nanopharmaceutics: Part I-Clinical Trials Legislation and Good Manufacturing Practices (GMP) of Nanotherapeutics in the EU |
title_full |
Nanopharmaceutics: Part I-Clinical Trials Legislation and Good Manufacturing Practices (GMP) of Nanotherapeutics in the EU |
title_fullStr |
Nanopharmaceutics: Part I-Clinical Trials Legislation and Good Manufacturing Practices (GMP) of Nanotherapeutics in the EU |
title_full_unstemmed |
Nanopharmaceutics: Part I-Clinical Trials Legislation and Good Manufacturing Practices (GMP) of Nanotherapeutics in the EU |
title_sort |
Nanopharmaceutics: Part I-Clinical Trials Legislation and Good Manufacturing Practices (GMP) of Nanotherapeutics in the EU |
author |
Souto, Eliana B. |
author_facet |
Souto, Eliana B. Silva, Gabriela F. Dias-Ferreira, João Zielińska, Aleksandra Ventura, Fátima Durazzo, Alessandra Lucarini, Massimo Novellino, Ettore Santini, Antonello |
author_role |
author |
author2 |
Silva, Gabriela F. Dias-Ferreira, João Zielińska, Aleksandra Ventura, Fátima Durazzo, Alessandra Lucarini, Massimo Novellino, Ettore Santini, Antonello |
author2_role |
author author author author author author author author |
dc.contributor.author.fl_str_mv |
Souto, Eliana B. Silva, Gabriela F. Dias-Ferreira, João Zielińska, Aleksandra Ventura, Fátima Durazzo, Alessandra Lucarini, Massimo Novellino, Ettore Santini, Antonello |
dc.subject.por.fl_str_mv |
nanopharmaceutics legislation clinical trials quality safety GMP |
topic |
nanopharmaceutics legislation clinical trials quality safety GMP |
description |
The latest advances in pharmaceutical technology are leading to the development of cutting edged approaches to produce what is now known as the "Holy Grail" of medicine-nanopharmaceutics. Over the latest decade, the pharmaceutical industry has made important contributions to the scale up of these new products. To ensure their quality, efficacy, and safety for human use, clinical trials are mandatory. Yet, regulation regarding nanopharmaceuticals is still limited with a set of guidelines being recently released with respect to compliance with quality and safety. For the coming years, updates on regulatory issues about nanopharmaceuticals and their use in clinical settings are expected. The use of nanopharmaceuticals in clinical trials depends on the approval of the production methods and assurance of the quality of the final product by implementation and verification of the good manufacturing practices (GMP). This review addresses the available legislation on nanopharmaceuticals within the European Union (EU), the GMP that should be followed for their production, and the current challenges encountered in clinical trials of these new formulations. The singular properties of nanopharmaceuticals over their bulk counterparts are associated with their size, matrix composition, and surface properties. To understand their relevance, four main clinical trial guidelines, namely, for intravenous iron-based nanopharmaceuticals, liposomal-based nanopharmaceuticals, block copolymer micelle-based nanopharmaceuticals, and related to surface coating requirements, are described here. |
publishDate |
2020 |
dc.date.none.fl_str_mv |
2020-02-11 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://hdl.handle.net/10316/106533 http://hdl.handle.net/10316/106533 https://doi.org/10.3390/pharmaceutics12020146 |
url |
http://hdl.handle.net/10316/106533 https://doi.org/10.3390/pharmaceutics12020146 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
1999-4923 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.publisher.none.fl_str_mv |
MDPI |
publisher.none.fl_str_mv |
MDPI |
dc.source.none.fl_str_mv |
reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação instacron:RCAAP |
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Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
instacron_str |
RCAAP |
institution |
RCAAP |
reponame_str |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
collection |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
repository.name.fl_str_mv |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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1799134117912117248 |