Risk (Re)assessment of N-Methyl-N-nitrosophenethylamine for use in computing risk levels of N-Nitrosamine drug substance related impurities

Woolley, David R.; Johnson, George; Cross, Kevin P.

doi:10.1016/j.yrtph.2025.105888

Journal article 359 views 81 downloads

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

Regulatory Toxicology and Pharmacology, Volume: 162, Start page: 105888

Swansea University Author: George Johnson

PDF | Accepted Manuscript

Author accepted manuscript document released under the terms of a Creative Commons CC-BY licence using the Swansea University Research Publications Policy (rights retention).
Download (486KB)

Check full text

DOI (Published version): 10.1016/j.yrtph.2025.105888

Published in:	Regulatory Toxicology and Pharmacology
ISSN:	0273-2300 1096-0295
Published:	Elsevier Inc. 2025
Online Access:	Check full text
URI:	https://cronfa.swan.ac.uk/Record/cronfa69759

first_indexed	2025-06-18T09:46:54Z
last_indexed	2025-07-22T05:03:58Z
id	cronfa69759
recordtype	SURis
fullrecord	<?xml version="1.0"?><rfc1807><datestamp>2025-07-21T11:49:50.1053955</datestamp><bib-version>v2</bib-version><id>69759</id><entry>2025-06-18</entry><title>Risk (Re)assessment of N-Methyl-N-nitrosophenethylamine for use in computing risk levels of N-Nitrosamine drug substance related impurities</title><swanseaauthors><author><sid>37d0f121db69fd09f364df89e4405e31</sid><ORCID>0000-0001-5643-9942</ORCID><firstname>George</firstname><surname>Johnson</surname><name>George Johnson</name><active>true</active><ethesisStudent>false</ethesisStudent></author></swanseaauthors><date>2025-06-18</date><deptcode>MEDS</deptcode><abstract/><type>Journal Article</type><journal>Regulatory Toxicology and Pharmacology</journal><volume>162</volume><journalNumber/><paginationStart>105888</paginationStart><paginationEnd/><publisher>Elsevier Inc.</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint>0273-2300</issnPrint><issnElectronic>1096-0295</issnElectronic><keywords>N-Methyl-N-Nitrosophenethylamine; N-Nitrosamines; Acceptable intake; Permitted daily exposure; Carcinogenicity potency database; ICH M7; Benchmark dose (BMD); Cohort of concern</keywords><publishedDay>1</publishedDay><publishedMonth>11</publishedMonth><publishedYear>2025</publishedYear><publishedDate>2025-11-01</publishedDate><doi>10.1016/j.yrtph.2025.105888</doi><url/><notes/><college>COLLEGE NANME</college><department>Medical School</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>MEDS</DepartmentCode><institution>Swansea University</institution><apcterm>Not Required</apcterm><funders>Instem; ForthTox; Swansea University</funders><projectreference/><lastEdited>2025-07-21T11:49:50.1053955</lastEdited><Created>2025-06-18T09:36:59.5616419</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">Swansea University Medical School - Biomedical Science</level></path><authors><author><firstname>David R.</firstname><surname>Woolley</surname><orcid>0000-0002-1637-4184</orcid><order>1</order></author><author><firstname>George</firstname><surname>Johnson</surname><orcid>0000-0001-5643-9942</orcid><order>2</order></author><author><firstname>Kevin P.</firstname><surname>Cross</surname><order>3</order></author></authors><documents><document><filename>69759__34509__078c532ef17948b7b254b9d079bde3d6.pdf</filename><originalFilename>69759.AAM.pdf</originalFilename><uploaded>2025-06-18T12:26:59.2188548</uploaded><type>Output</type><contentLength>497664</contentLength><contentType>application/pdf</contentType><version>Accepted Manuscript</version><cronfaStatus>true</cronfaStatus><documentNotes>Author accepted manuscript document released under the terms of a Creative Commons CC-BY licence using the Swansea University Research Publications Policy (rights retention).</documentNotes><copyrightCorrect>true</copyrightCorrect><language>eng</language><licence>https://creativecommons.org/licenses/by/4.0/</licence></document></documents><OutputDurs/></rfc1807>
spelling	2025-07-21T11:49:50.1053955 v2 69759 2025-06-18 Risk (Re)assessment of N-Methyl-N-nitrosophenethylamine for use in computing risk levels of N-Nitrosamine drug substance related impurities 37d0f121db69fd09f364df89e4405e31 0000-0001-5643-9942 George Johnson George Johnson true false 2025-06-18 MEDS Journal Article Regulatory Toxicology and Pharmacology 162 105888 Elsevier Inc. 0273-2300 1096-0295 N-Methyl-N-Nitrosophenethylamine; N-Nitrosamines; Acceptable intake; Permitted daily exposure; Carcinogenicity potency database; ICH M7; Benchmark dose (BMD); Cohort of concern 1 11 2025 2025-11-01 10.1016/j.yrtph.2025.105888 COLLEGE NANME Medical School COLLEGE CODE MEDS Swansea University Not Required Instem; ForthTox; Swansea University 2025-07-21T11:49:50.1053955 2025-06-18T09:36:59.5616419 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Biomedical Science David R. Woolley 0000-0002-1637-4184 1 George Johnson 0000-0001-5643-9942 2 Kevin P. Cross 3 69759__34509__078c532ef17948b7b254b9d079bde3d6.pdf 69759.AAM.pdf 2025-06-18T12:26:59.2188548 Output 497664 application/pdf Accepted Manuscript true Author accepted manuscript document released under the terms of a Creative Commons CC-BY licence using the Swansea University Research Publications Policy (rights retention). true eng https://creativecommons.org/licenses/by/4.0/
title	Risk (Re)assessment of N-Methyl-N-nitrosophenethylamine for use in computing risk levels of N-Nitrosamine drug substance related impurities
spellingShingle	Risk (Re)assessment of N-Methyl-N-nitrosophenethylamine for use in computing risk levels of N-Nitrosamine drug substance related impurities George Johnson
title_short	Risk (Re)assessment of N-Methyl-N-nitrosophenethylamine for use in computing risk levels of N-Nitrosamine drug substance related impurities
title_full	Risk (Re)assessment of N-Methyl-N-nitrosophenethylamine for use in computing risk levels of N-Nitrosamine drug substance related impurities
title_fullStr	Risk (Re)assessment of N-Methyl-N-nitrosophenethylamine for use in computing risk levels of N-Nitrosamine drug substance related impurities
title_full_unstemmed	Risk (Re)assessment of N-Methyl-N-nitrosophenethylamine for use in computing risk levels of N-Nitrosamine drug substance related impurities
title_sort	Risk (Re)assessment of N-Methyl-N-nitrosophenethylamine for use in computing risk levels of N-Nitrosamine drug substance related impurities
author_id_str_mv	37d0f121db69fd09f364df89e4405e31
author_id_fullname_str_mv	37d0f121db69fd09f364df89e4405e31_***_George Johnson
author	George Johnson
author2	David R. Woolley George Johnson Kevin P. Cross
format	Journal article
container_title	Regulatory Toxicology and Pharmacology
container_volume	162
container_start_page	105888
publishDate	2025
institution	Swansea University
issn	0273-2300 1096-0295
doi_str_mv	10.1016/j.yrtph.2025.105888
publisher	Elsevier Inc.
college_str	Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id	facultyofmedicinehealthandlifesciences
hierarchy_top_title	Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id	facultyofmedicinehealthandlifesciences
hierarchy_parent_title	Faculty of Medicine, Health and Life Sciences
department_str	Swansea University Medical School - Biomedical Science{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Biomedical Science
document_store_str	1
active_str	0
published_date	2025-11-01T05:29:01Z
_version_	1851097917546299392
score	11.089407

Risk (Re)assessment of N-Methyl-N-nitrosophenethylamine for use in computing risk levels of N-Nitrosamine drug substance related impurities

Similar Items