International Journal on Science and Technology

E-ISSN: 2229-7677   •   Impact Factor: 9.88

A Widely Indexed Open Access Peer Reviewed Multidisciplinary Bi-monthly Scholarly International Journal

Call for Paper Volume 16 Issue 2 April-June 2025 Submit your research before last 3 days of June to publish your research paper in the issue of April-June.
Submit Research Paper Join as a Reviewer

Plagiarism is checked by the leading plagiarism checker TurnItIn

Call for Paper

Volume 16 Issue 2
April-June 2025

Submit your research paper

Indexing Partners
Academia Advanced Sciences Index Bielefeld Academic Search Engine CiteSeer DRJI Google Scholar Independent Search Engine & Directory Network ISI (International Scientific Indexing) Issuu Mendeley Research Networks
RefSeek ResearcherId - Thomson Reuters ResearchGate Scirus Scribd Semantic Scholar UTeM - Universiti Teknikal Malaysia Melaka Wiki for Call for Papers WorldCat Zenodo

Mitigating the Molecular Threat: A Review of Carcinogenic and Mutagenic Agents in Pharmaceuticals

Author(s) Rashmita K Akkatangerhal, Panchaxari M. Dandagi
Country India
Abstract The safety of pharmaceutical products is a critical concern in drug development, particularly regarding their potential to induce carcinogenicity and mutagenicity. Carcinogenic and mutagenic agents may be present as active ingredients, degradation products, or manufacturing-related impurities, posing significant risks to patient health. This review provides a comprehensive analysis of the mechanisms by which pharmaceutical substances can induce genetic damage, with particular attention to DNA damage, epigenetic modifications, and reactive metabolite formation. It also compares genotoxic and non-genotoxic pathways of carcinogenesis and highlights common high-risk agents such as alkylating compounds, topoisomerase inhibitors, and nitrosamines. Emphasis is placed on global regulatory frameworks, including ICH M7 and related FDA and EMA guidelines, which mandate rigorous risk assessment and impurity control. The review further explores analytical tools such as in vitro and in vivo assays, high-throughput screening, and in silico predictive models used to evaluate genotoxic potential. Finally, current and emerging mitigation strategies are discussed, ranging from process optimization to AI-driven compound design and international regulatory harmonization. These insights aim to inform safer pharmaceutical development by preventing harmful genetic interactions and ensuring long-term patient safety.
Keywords : Carcinogenicity, Mutagenicity, Genotoxic impurities, Pharmaceutical safety, DNA damage, Epigenetic alterations
Field Medical / Pharmacy
Published In Volume 16, Issue 2, April-June 2025
Published On 2025-05-31
DOI https://doi.org/10.71097/IJSAT.v16.i2.5730
Short DOI https://doi.org/g9m29d
View / Download PDF File

Share this


CrossRef

CrossRef DOI is assigned to each research paper published in our journal.

IJSAT DOI prefix is
10.71097/IJSAT

Downloads
Research Paper Format Copyright Permission Form and Undertaking Form Cover Page Vol 15 Isu 4Cover Page Vol 15 Isu 3Cover Page Vol 15 Isu 2

All research papers published on this website are licensed under Creative Commons Attribution-ShareAlike 4.0 International License, and all rights belong to their respective authors/researchers.

CC-BY-SA Open Access

About IJSAT
Fees & Payment
Current Issue
Publication Archive 		Submit Research Paper
Track Submission Status
Publication Guidelines
Publication Ethics
Peer Review & Plagiarism 		Join as a Reviewer
Editors & Reviewers
Reviewer Referral Program
Get Reviewer Membership Certi. 		Website/Journal Policies
Usage Policy
Content Policies
Privacy Policy
Contact Us Message on WhatsApp +91-9687-182-185 editor@ijsat.org