Discover Community Create You

Loading publication...

Noodle always counts identifier-free feature events for service operation. With your permission, Google Analytics can also estimate audience and engagement. Search text, publication identifiers, cookies, IP addresses and browser fingerprints are never included in Noodle's first-party event counters.

Privacy details

Article

Use of the bacterial reverse mutation assay to predict carcinogenicity of N-nitrosamines.

Regulatory toxicology and pharmacology : RTP - 1 Nov 2022

Trejo-Martin Alejandra, Bercu Joel P, Thresher Andrew, Tennant Rachael E, Thomas Robert F, Cross Kevin, Czich Andreas, Waese Kerstin, Nicolette John J, Murray Joel, Sonders Paul, Kondratiuk Alison, Cheung Jennifer R, Thomas Dean, Lynch Anthony, Harvey James, Glowienke Susanne, Custer Laura, Escobar Patricia A

Abstract excerpt

Under ICH M7, impurities are assessed using the bacterial reverse mutation assay (i.e., Ames test) when predicted positive using in silico methodologies followed by expert review. N-Nitrosamines (NAs) have been of recent concern as impurities in pharmaceuticals, mainly because of their potential to be highly potent mutagenic carcinogens in rodent bioassays. The purpose of this analysis was to determine the...

Read the complete abstract on PubMed

Topics

Share this publication in a Topic to start or enrich a Post.

Share to Bacteria
Share to Biological Assay

Methodology Data sources Editorial policy Privacy Delete account & data About Contact Helena Bioinformatics

Share to Carcinogens

Share to Dimethyl Sulfoxide

Share to Nitrosamines

Share to Pharmaceutical Preparations

Share to Rodentia

Share to Solvents

Source

Identifiers

PMID: 35998738
DOI: 10.1016/j.yrtph.2022.105247

Provenance

PubMed metadata and Literature Corpus relationships. Corpus snapshot updated 7 Sept 2026. Manifest publication-graph-cohort-2026-09-08.1.

Source receipt: pubmed, retrieved 7 Sept 2026.

Related research

Semantic proximity does not establish scientific evidence. Graph snapshot: 2026-09-29.

Research trail→

Click a neighbor to travelStep 1 · 12 closest

Use of the bacterial reverse mutation assay to predict carcinogenicity of N-nitrosamines.PMID 35998738Read ↗

Ames concordance with the in vivo transgenic rodent (TGR) gene mutation assay for NDSRIs and relative in vivo TGR potency with nitrosamines with robust dose-response carcinogenicity data.Semantic proximity Read ↗

Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays.Semantic proximity Read ↗

Comparative evaluation of three methylene dianiline isomers in the bacterial reverse mutation assay, the in vitro gene mutation test, and the in vitro chromosomal aberration test.Semantic proximity Read ↗

N-nitrosamine impurity risk assessment in pharmaceuticals: Utilizing In vivo mutation relative potency comparison to establish an acceptable intake for NTTP.Semantic proximity Read ↗

Alternatives to the carcinogenicity bioassay:<i>in silico</i>methods, and the<i>in vitro</i>and<i>in vivo</i>mutagenicity assaysSemantic proximity Read ↗

Assessing the impact of different solvents in the bacterial reverse mutation test.Semantic proximity Read ↗

Bacterial Reverse Mutation Test: Ames Test.Semantic proximity Read ↗

Mutagenicity and genotoxicity evaluation of 15 nitrosamine drug substance-related impurities in human TK6 cells.Semantic proximity Read ↗

Bacterial mutagenicity screening in the pharmaceutical industry.Semantic proximity Read ↗

Bacterial mutation assays.Semantic proximity Read ↗

Mutagenicity Evaluation of Nanoparticles by the Ames Assay.Semantic proximity Read ↗

Differential Genotoxicity of Polygoni Multiflori in Rat and Human: Insights from Ames Test and S9 Metabolic Activation SystemSemantic proximity Read ↗

⌁Select a neighboring publication to make it the new centre.