ReviewGenes and environment : the official journal of the Japanese Environmental Mutagen Society2025
Guidelines for the assessment and control of mutagenic impurities in pharmaceuticals.
Review in Genes and environment : the official journal of the Japanese Environmental Mutagen Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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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.
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.
Who cites it
2 citing papers in PubMed.
- Prediction of Ocular Toxicity of Prostaglandin FMolecules (Basel, Switzerland) · 2026Article
- Artificial Intelligence as a Disruptive Force in Pharmaceutical Innovation: Transforming Discovery, Development, and Manufacturing.Drug design, development and therapy · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Pharmaceuticals may contain trace impurities unrelated to therapeutic activity, which may occur as synthetic intermediates or degradation products. Among these impurities, mutagenic impurities are of particular concern, as even very low levels of exposure can increase the risk of cancer in humans. To address this issue, the International Council on Harmonization (ICH) developed the M7 guideline in 2014, which aim to provide a scientific and practical framework for the assessment and control of mutagenic impurities in pharmaceuticals. The M7 guideline has been updated twice, in 2017 (R1) and 2023 (R2), with the addition of addendum defining compound-specific acceptable intake levels and a comprehensive Q&A document to promote harmonized implementation. Recent cases involving N-nitrosamine impurities have highlighted the need for improved risk assessment methods due to their high carcinogenic potential. The latest revision of the M7 guidelines (M7(R3)) will introduce a new approach to consider the quantitative carcinogenic potential of N-nitrosamines based on their structural characteristics.
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Registered trials
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.