Mechanisms of Nitrosamine Mutagenicity and Their Relationship to Rodent Carcinogenic Potency-Reference-Cited by-同舟云学术

Mechanisms of Nitrosamine Mutagenicity and Their Relationship to Rodent Carcinogenic Potency

Published:2024-02-05 Issue: Volume: Page:
ISSN:0893-228X
Container-title:Chemical Research in Toxicology
language:en
Short-container-title:Chem. Res. Toxicol.

Author:

Snodin David J.¹^ORCID,Trejo-Martin Alejandra²,Ponting David J.³^ORCID,Smith Graham F.⁴^ORCID,Czich Andreas⁵,Cross Kevin⁶,Custer Laura⁷,Elloway Joanne⁸,Greene Nigel⁹,Kalgutkar Amit S.¹⁰^ORCID,Stalford Susanne A.³,Tennant Rachael E.³,Vock Esther¹¹,Zalewski Adam¹²^ORCID,Ziegler Verena¹²,Dobo Krista L.¹³^ORCID

Affiliation:

1. Xiphora Biopharma Consulting, Bristol BS6 7BG, U.K.

2. Gilead Sciences Inc. Nonclinical Safety and Pathobiology (NSP), Foster City, California 94404, United States

3. Lhasa Limited, Granary Wharf House, Leeds, LS11 5PS, U.K.

4. AstraZeneca, Imaging and Data Analytics, Clinical Pharmacology and Safety Sciences, Research and Development, CB2 0AA Cambridge, U.K.

5. Sanofi, Research and Development, Preclinical Safety, 65926 Frankfurt, Germany

6. Instem, Conshohocken, Pennsylvania 19428, United States

7. Bristol-Myers Squibb, Nonclinical Safety, New Brunswick, New Jersey 08903, United States

8. AstraZeneca, Safety Sciences, Clinical Pharmacology and Safety Sciences Research and Development, CB2 0AA Cambridge, U.K.

9. AstraZeneca, Imaging and Data Analytics, Clinical Pharmacology and Safety Sciences, Research and Development, Waltham, Massachusetts 02451, United States

10. Medicine Design, Pfizer Worldwide Research, Development, and Medical, Cambridge, Massachusetts 02139, United States

11. Boehringer-Ingelheim Pharma GmbH & Co., KG, 88397 Biberach an der Riss, Germany

12. Bayer AG, Pharmaceuticals, Genetic and Computational Toxicology, 13342 Berlin, Germany

13. Drug Safety Research and Development, Global Portfolio and Regulatory Strategy, Pfizer Worldwide Research, Development, and Medical, Groton, Connecticut 06340, United States

Publisher

American Chemical Society (ACS)

Subject

Toxicology,General Medicine

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.chemrestox.3c00327

Reference119 articles.

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2. Structure-based thresholds of toxicological concern (TTC): guidance for application to substances present at low levels in the diet

3. International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. ICH M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk M7; U.S. FDA, 2023.

4. Are all nitrosamines concerning? A review of mutagenicity and carcinogenicity data

5. Mutagenic impurities in pharmaceuticals: A critical assessment of the cohort of concern with a focus on N-nitrosamines