Mechanisms of Nitrosamine Mutagenicity and Their Relationship to Rodent Carcinogenic Potency

Author:

Snodin David J.1ORCID,Trejo-Martin Alejandra2,Ponting David J.3ORCID,Smith Graham F.4ORCID,Czich Andreas5,Cross Kevin6,Custer Laura7,Elloway Joanne8,Greene Nigel9,Kalgutkar Amit S.10ORCID,Stalford Susanne A.3,Tennant Rachael E.3,Vock Esther11,Zalewski Adam12ORCID,Ziegler Verena12,Dobo Krista L.13ORCID

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)

Reference119 articles.

1. A tiered approach to threshold of regulation

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

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