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Regulatory safety evaluation of nanomedical products: key issues to refine

Nanotechnologies enable great opportunities for the development and use of innovative (nano)medicines. As is common for scientific and technical developments, recognized safety evaluation methods for regulatory purposes are lagging behind. The specific properties responsible for the desired function...

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Detalles Bibliográficos
Autores principales: De Jong, Wim H., Geertsma, Robert E., Borchard, Gerrit
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9358921/
https://www.ncbi.nlm.nih.gov/pubmed/35908133
http://dx.doi.org/10.1007/s13346-022-01208-4
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author De Jong, Wim H.
Geertsma, Robert E.
Borchard, Gerrit
author_facet De Jong, Wim H.
Geertsma, Robert E.
Borchard, Gerrit
author_sort De Jong, Wim H.
collection PubMed
description Nanotechnologies enable great opportunities for the development and use of innovative (nano)medicines. As is common for scientific and technical developments, recognized safety evaluation methods for regulatory purposes are lagging behind. The specific properties responsible for the desired functioning also hamper the safety evaluation of such products. Pharmacokinetics determination of the active pharmaceutical ingredient as well as the nanomaterial component is crucial. Due to their particulate nature, nanomedicines, similar to all nanomaterials, are primarily removed from the circulation by phagocytizing cells that are part of the immune system. Therefore, the immune system can be potentially a specific target for adverse effects of nanomedicines, and thus needs special attention during the safety evaluation. This DDTR special issue on the results of the REFINE project on a regulatory science framework for nanomedical products presents a highly valuable body of knowledge needed to address regulatory challenges and gaps in currently available testing methods for the safety evaluation of nanomedicines.
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spelling pubmed-93589212022-08-09 Regulatory safety evaluation of nanomedical products: key issues to refine De Jong, Wim H. Geertsma, Robert E. Borchard, Gerrit Drug Deliv Transl Res Inspirational Note Nanotechnologies enable great opportunities for the development and use of innovative (nano)medicines. As is common for scientific and technical developments, recognized safety evaluation methods for regulatory purposes are lagging behind. The specific properties responsible for the desired functioning also hamper the safety evaluation of such products. Pharmacokinetics determination of the active pharmaceutical ingredient as well as the nanomaterial component is crucial. Due to their particulate nature, nanomedicines, similar to all nanomaterials, are primarily removed from the circulation by phagocytizing cells that are part of the immune system. Therefore, the immune system can be potentially a specific target for adverse effects of nanomedicines, and thus needs special attention during the safety evaluation. This DDTR special issue on the results of the REFINE project on a regulatory science framework for nanomedical products presents a highly valuable body of knowledge needed to address regulatory challenges and gaps in currently available testing methods for the safety evaluation of nanomedicines. Springer US 2022-07-30 2022 /pmc/articles/PMC9358921/ /pubmed/35908133 http://dx.doi.org/10.1007/s13346-022-01208-4 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Inspirational Note
De Jong, Wim H.
Geertsma, Robert E.
Borchard, Gerrit
Regulatory safety evaluation of nanomedical products: key issues to refine
title Regulatory safety evaluation of nanomedical products: key issues to refine
title_full Regulatory safety evaluation of nanomedical products: key issues to refine
title_fullStr Regulatory safety evaluation of nanomedical products: key issues to refine
title_full_unstemmed Regulatory safety evaluation of nanomedical products: key issues to refine
title_short Regulatory safety evaluation of nanomedical products: key issues to refine
title_sort regulatory safety evaluation of nanomedical products: key issues to refine
topic Inspirational Note
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9358921/
https://www.ncbi.nlm.nih.gov/pubmed/35908133
http://dx.doi.org/10.1007/s13346-022-01208-4
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