Evidence map›Paper›PMID 33170166›Full record

ReviewActa bio-medica : Atenei Parmensis2020

Comparison between American and European legislation in the therapeutical and alimentary bacteriophage usage.

Zakira Naureen, Daniele Malacarne, Kyrylo Anpilogov, Astrit Dautaj, Giorgio Camilleri, Stefano Cecchin, Simone Bressan, Arianna Casadei, Elena Albion, Elisa Sorrentino and 3 more

Open access · greenAbstract readReview
In one paragraph

Review in Acta bio-medica : Atenei Parmensis, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
2.4field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 31 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Review
  5. Effect of egg cultivation methods onFood science and biotechnology · 2025
    Article
  6. Review
  7. Review
  8. Review
  9. Article
  10. In Vitro Susceptibility of Clinical and Carrier Strains ofInternational journal of molecular sciences · 2024
    Article
  11. Review
  12. Review
  13. Phage-Based Biosanitation Strategies for Minimizing PersistentAnimals : an open access journal from MDPI · 2023
    Review
  14. Article
  15. Article
  16. Review
  17. Review
  18. Review
  19. Regulations of phage therapy across the world.Frontiers in microbiology · 2023
    Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 5 institutions in 3 countries.

Zakira NaureenDepartment of Biological Sciences and Chemistry, College of Arts and Sciences, University of Nizwa, Nizwa, Oman. zakiranaureen@gmail.com.
Daniele MalacarneMAGI'S LAB, Rovereto (TN), Italy. daniele.malacarne@assomagi.org.
Kyrylo AnpilogovMAGI EUREGIO, Bolzano, Italy. kirill.anpilogov@assomagi.org.
Astrit DautajEBTNA-LAB, Rovereto (TN), Italy. astrit.dautaj@assomagi.org.
Giorgio CamilleriMAGI'S LAB, Rovereto (TN), Italy. giorgio.camilleri@assomagi.org.
Stefano CecchinMAGI'S LAB, Rovereto (TN), Italy. laboratorio@assomagi.org.
Simone BressanMAGI'S LAB, Rovereto (TN), Italy. simone.bressan@assomagi.org.
Arianna CasadeiMAGI EUREGIO, Bolzano, Italy. arianna.casadei@assomagi.org.
Elena AlbionMAGI EUREGIO, Bolzano, Italy. elena.albion@assomagi.org.
Elisa SorrentinoMAGI EUREGIO, Bolzano, Italy. elisa.sorrentino@assomagi.org.
Tommaso BeccariDepartment of Pharmaceutical Sciences, University of Perugia, Perugia, Italy. tommaso.beccari@unipg.it.
Munis DundarDepartment of Medical Genetics, Erciyes University Medical School, Kayseri, Turkey. dundar@erciyes.edu.tr.
Matteo BertelliMAGI'S LAB, Rovereto (TN), Italy; MAGI EUREGIO, Bolzano, Italy; EBTNA-LAB, Rovereto (TN), Italy. matteo.bertelli@assomagi.org.
Center for Neuroscience and Cognitive Systems · ITEurac Research · ITErciyes University · TRUniversity of Nizwa · OMUniversity of Perugia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

BacteriophagesEuropean UnionHumansUnited States

Identifiers

PMID33170166
PMCPMC8023134
OpenAlexW3101047875

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.