Evidence mapPaperPMID 39844559Full record

ReviewCurrent pharmaceutical biotechnology2026

Navigating Regulatory Frameworks and Compliances for Bacteriophages as Therapeutic Agents.

Shilpa Deshpande Kaistha, Pramila Devi, Nisha Sharma, Sadhana Sagar

Abstract readReview
PubMed Publisher
In one paragraph

Review in Current pharmaceutical biotechnology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
field-weighted citation impact
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

3 citing papers in PubMed.

  1. Review
  2. Review
  3. 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

4 authors.

Shilpa Deshpande KaisthaDepartment of Biotechnology, School of Life Sciences & Biotechnology, Chhatrapati Shahu Ji Maharaj University, Kanpur, 208024, UP, India.ORCID 0000-0002-2196-7224
Pramila DeviDepartmentof Microbiology, School of Life Sciences & Biotechnology, Chhatrapati Shahu Ji Maharaj University, Kanpur, 208024, UP, India.
Nisha SharmaSchool of Pharmaceutical Sciences, Chhatrapati Shahu Ji Maharaj University, Kanpur, 208024, UP, India.
Sadhana SagarCaliciviruses Section, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Funding

UP HEI COE 45/2022/869/4-2022/001-70-4099-1-2022
6 · The paper itself

Abstract

The emergence of multiple antibiotic resistance in recurrent bacterial infections has led to exploring alternative therapeutic options, including using bacteria lysing viruses [bacteriophages] to control recalcitrant infections. Bacteriophages [Phage] and their end products such as enzymes, virus-like particles, and vectors are being used for varied applications such as basic and applied research for the field of phage therapeutics. Phage-based products and services such as viral vectors for gene therapy/vaccines, imaging agents, diagnostics as well as drug delivery agents form a wide range of useful innovative therapeutics that are under development. Regulatory compliances are hence essential for safely implementing phage in varied applications. Product compliances ensure safety, efficacy, stability, and quality control in preclinical as well as manufacturing and marketing processes. A well-established regulatory framework ensures innovative product development with high rates of successful clinical translation and development of phage therapeutics as effective alternatives to antibiotics or for consideration in integrated pathogen management strategies. This review highlights the importance of regulatory standards in different stages of phage therapy- during preclinical research as well as different regulatory bodies in the manufacturing, clinical evaluation, and market approval of phage-based products. Global trends in facilitating phage therapeutics' regulatory frameworks and compliances are discussed.

Indexed as

Bacterial InfectionsBacteriophagesPhage TherapyAnimalsHumansgene therapy/vaccinesinvestigational new drugmagistral drugphage regulatory bodiesPhage therapeuticsphage therapy

Identifiers

What Socratic holds

Textmetadata
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 Socratic graph.