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Risk (Re)assessment of N-Methyl-N-nitrosophenethylamine for use in computing risk levels of N-Nitrosamine drug substance related impurities
David R. Woolley 
,
George Johnson ,
Kevin P. Cross
,
George Johnson ,
Kevin P. Cross
Regulatory Toxicology and Pharmacology, Volume: 162, Start page: 105888
Swansea University Author:
George Johnson
-
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Author accepted manuscript document released under the terms of a Creative Commons CC-BY licence using the Swansea University Research Publications Policy (rights retention).
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DOI (Published version): 10.1016/j.yrtph.2025.105888
Abstract
Risk (Re)assessment of N-Methyl-N-nitrosophenethylamine for use in computing risk levels of N-Nitrosamine drug substance related impurities
| Published in: | Regulatory Toxicology and Pharmacology |
|---|---|
| ISSN: | 0273-2300 1096-0295 |
| Published: |
Elsevier Inc.
2025
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| Online Access: |
Check full text
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| URI: | https://cronfa.swan.ac.uk/Record/cronfa69759 |
| Keywords: |
N-Methyl-N-Nitrosophenethylamine; N-Nitrosamines; Acceptable intake; Permitted daily exposure; Carcinogenicity potency database; ICH M7; Benchmark dose (BMD); Cohort of concern |
|---|---|
| College: |
Faculty of Medicine, Health and Life Sciences |
| Funders: |
Instem; ForthTox; Swansea University |
| Start Page: |
105888 |