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7 results for “nitrosamines”
Evolution of FDA Guidelines on Control of Nitrosamine Impurities in Human Drugs – A Comparative Analysis of September 2024 Revisions
<p>Nitrosamine impurities have become a significant concern in the pharmaceutical industry due to their carcinogenic potential. In response, the U.S. Food and Drug Administration (FDA) has continuously updated its guidelines to ensure the safety and efficacy of drug products. This review article provides a comprehensive analysis of the evolution of FDA guidelines on the control of nitrosamine impurities, with a particular focus on the September 2024 revisions. By comparing the latest guidance with previous versions, this article highlights key changes, including the expanded focus on Nitrosamine Drug Substance-Related Impurities (NDSRIs), updated risk assessment strategies, and the introduction of new Acceptable Intake (AI) limits. The analysis underscores the FDA's commitment to enhancing drug safety through rigorous control measures and global harmonization efforts.</p>
Occurrence data on N-nitrosamines provided to EFSA
<p>The file contains the raw occurrence dataset on nitrosamines in food as extracted from EFSA DWH on 3 July 2021 and presented in the EFSA opinion on Risk assessment of N-nitrosamines in food available at https://doi.org/10.2903/j.efsa.2023.7884. The data is provided in csv format. This dataset is compliant with EFSA SSD2 data model and contains two additional columns documenting issues identified in the cleaning process (column: issue) and the action taken (column: action) to address the issue (e.g. delete record or update values in specific fields).</p> <p>The link to the catalogues of controlled terminologies for the updated textual description of fields values can be found under "Related identifiers”.</p>
Nitrate INFORMER Nitrosamine Study
ClinicalTrials.gov study NCT05045807. IPD Sharing: NO. Countries: 1. Publications: 18.
Genotoxicity of nitrosamines
GEO Series GSE110906. Gallus gallus. 8 samples. Type: Expression profiling by array.
Whole transcriptome sequencing for upper tract urothelial carcinoma (UTUC) of BALB/c female mice treated with N-butyl-N-(4-hydroxybutyl) nitrosamine (BBN)
GEO Series GSE274057. Mus musculus. 37 samples. Type: Expression profiling by high throughput sequencing.
In-vivo Extraction of Lead, Cadmium and Tobacco Specific Nitrosamines From Swedish 'Snus' in Regular Snus Users
ClinicalTrials.gov study NCT01838473. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Whole genome gene expression modifications associated with micronucleus formation in blood cells from nitrosamine-exposed humans
GEO Series GSE23919. Homo sapiens. 30 samples. Type: Expression profiling by array.
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Allen Brain Atlas
Allen Brain Atlas is an Allen Institute collection of brain map atlases, datasets, APIs, and analysis tools covering mouse, human, and non-human primate brain resources.
Annotated Behaviour and Observability Dataset (ABODe)
ABODe is a University of Edinburgh DataShare dataset for behavior classification in group-housed mice using home-cage video, identities, bounding boxes, ground-plate positions, and annotator labels.
DANDI Archive for NWB datasets
DANDI is a BRAIN Initiative archive for publishing and sharing neurophysiology data, including electrophysiology, optophysiology, and behavioral data packaged as NWB and related standards.
International Brain Laboratory public data
The International Brain Laboratory public data releases expose standardized mouse decision-making experiments, including Neuropixels recordings, widefield calcium imaging, behavior, and session metadata accessed through the ONE API.
OpenNeuro
OpenNeuro is a free, open platform for sharing neuroimaging datasets, with public search, dataset pages, and download paths for web, S3, DataLad, and the OpenNeuro CLI.