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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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Mattioli 1885 2020
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)
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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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