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Comparison between American and European legislation in the therapeutical and alimentary bacteriophage usage
Bacteriophages, though discovered a century ago, still lag behind in the race of antimicrobials due to scarce information about their biology, pharmacology, safety and suitability as therapeutic agents. Although they possess several capabilities of practical utility in medicine, they are still unabl...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Mattioli 1885
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8023134/ https://www.ncbi.nlm.nih.gov/pubmed/33170166 http://dx.doi.org/10.23750/abm.v91i13-S.10815 |
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author | Naureen, Zakira Malacarne, Daniele Anpilogov, Kyrylo Dautaj, Astrit Camilleri, Giorgio Cecchin, Stefano Bressan, Simone Casadei, Arianna Albion, Elena Sorrentino, Elisa Beccari, Tommaso Dundar, Munis Bertelli, Matteo |
author_facet | Naureen, Zakira Malacarne, Daniele Anpilogov, Kyrylo Dautaj, Astrit Camilleri, Giorgio Cecchin, Stefano Bressan, Simone Casadei, Arianna Albion, Elena Sorrentino, Elisa Beccari, Tommaso Dundar, Munis Bertelli, Matteo |
author_sort | Naureen, Zakira |
collection | PubMed |
description | Bacteriophages, though discovered a century ago, still lag behind in the race of antimicrobials due to scarce information about their biology, pharmacology, safety and suitability as therapeutic agents. Although they possess several capabilities of practical utility in medicine, they are still unable to satisfy the regulatory standards set by the regulatory authorities in both United States (US) and European Union (EU). Bacteriophages and their products (lysins) are considered as drugs, therefore they should follow the same route of the chemical drugs in order to achieve regulatory approvals for commercial production and application. However, lack of definitive guidelines and regulations has rendered bacteriophages less attractive to pharmaceutical companies and funding agencies, making it difficult for clinicians and researchers to set up wide scale clinical trials in order to prove efficacy, safety and stability of bacteriophages and their products. In this review, we will discuss the current regulations for developing phages and phage-based products for therapeutic purposes in the US and EU. (www.actabiomedica.it) |
format | Online Article Text |
id | pubmed-8023134 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Mattioli 1885 |
record_format | MEDLINE/PubMed |
spelling | pubmed-80231342021-04-07 Comparison between American and European legislation in the therapeutical and alimentary bacteriophage usage Naureen, Zakira Malacarne, Daniele Anpilogov, Kyrylo Dautaj, Astrit Camilleri, Giorgio Cecchin, Stefano Bressan, Simone Casadei, Arianna Albion, Elena Sorrentino, Elisa Beccari, Tommaso Dundar, Munis Bertelli, Matteo Acta Biomed Review Bacteriophages, though discovered a century ago, still lag behind in the race of antimicrobials due to scarce information about their biology, pharmacology, safety and suitability as therapeutic agents. Although they possess several capabilities of practical utility in medicine, they are still unable to satisfy the regulatory standards set by the regulatory authorities in both United States (US) and European Union (EU). Bacteriophages and their products (lysins) are considered as drugs, therefore they should follow the same route of the chemical drugs in order to achieve regulatory approvals for commercial production and application. However, lack of definitive guidelines and regulations has rendered bacteriophages less attractive to pharmaceutical companies and funding agencies, making it difficult for clinicians and researchers to set up wide scale clinical trials in order to prove efficacy, safety and stability of bacteriophages and their products. In this review, we will discuss the current regulations for developing phages and phage-based products for therapeutic purposes in the US and EU. (www.actabiomedica.it) Mattioli 1885 2020 2020-11-09 /pmc/articles/PMC8023134/ /pubmed/33170166 http://dx.doi.org/10.23750/abm.v91i13-S.10815 Text en Copyright: © 2020 ACTA BIO MEDICA SOCIETY OF MEDICINE AND NATURAL SCIENCES OF PARMA http://creativecommons.org/licenses/by-nc-sa/4.0 This work is licensed under a Creative Commons Attribution 4.0 International License |
spellingShingle | Review Naureen, Zakira Malacarne, Daniele Anpilogov, Kyrylo Dautaj, Astrit Camilleri, Giorgio Cecchin, Stefano Bressan, Simone Casadei, Arianna Albion, Elena Sorrentino, Elisa Beccari, Tommaso Dundar, Munis Bertelli, Matteo Comparison between American and European legislation in the therapeutical and alimentary bacteriophage usage |
title | Comparison between American and European legislation in the therapeutical and alimentary bacteriophage usage |
title_full | Comparison between American and European legislation in the therapeutical and alimentary bacteriophage usage |
title_fullStr | Comparison between American and European legislation in the therapeutical and alimentary bacteriophage usage |
title_full_unstemmed | Comparison between American and European legislation in the therapeutical and alimentary bacteriophage usage |
title_short | Comparison between American and European legislation in the therapeutical and alimentary bacteriophage usage |
title_sort | comparison between american and european legislation in the therapeutical and alimentary bacteriophage usage |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8023134/ https://www.ncbi.nlm.nih.gov/pubmed/33170166 http://dx.doi.org/10.23750/abm.v91i13-S.10815 |
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