In Silico Prediction of N-Nitrosamine Formation Pathways of Pharmaceutical Products-Reference-Cited by-同舟云学术

In Silico Prediction of N-Nitrosamine Formation Pathways of Pharmaceutical Products

Published:2024-02-01 Issue:2 Volume:72 Page:166-172
ISSN:0009-2363
Container-title:Chemical and Pharmaceutical Bulletin
language:en
Short-container-title:Chem. Pharm. Bull.

Author:

Tsuji Genichiro¹,Kurohara Takashi¹,Shoda Takuji¹,Yokoo Hidetomo¹,Ito Takahito¹,Masada Sayaka¹,Uchiyama Nahoko¹,Yamamoto Eiichi¹,Demizu Yosuke¹

Affiliation:

1. National Institute of Health Sciences

Publisher

Pharmaceutical Society of Japan

Link

https://www.jstage.jst.go.jp/article/cpb/72/2/72_c23-00550/_pdf

Reference26 articles.

1. 1) Beard J. C., Seager T. M., J. Org. Chem., 86, 2037–2057 (2021).

2. 2) U.S. Food and Drug Administration, “Information about Nitrosamine Impurities in Medications.”: ‹https://www.fda.gov/drugs/drug-safety-and-availability/information-about-nitrosamine-impurities-medications›, cited 3 August, 2023.

3. 3) European Medicines Agency, “Nitrosamine impurities.”: ‹https://www.ema.europa.eu/en/human-regulatory/post-authorisation/referral-procedures/nitrosamine-impurities›, cited 3 August, 2023.

4. 4) Ministry of Health Labour and Welfare of Japan, “Self-inspection on Risks of Contamination with Nitrosamines in Drugs.”: ‹https://www.pmda.go.jp/files/000243438.pdf›, cited 31 March, 2020.

5. 5) European Medicines Agency, “ICH guideline M7(R1) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk.”: ‹https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-m7r1-assessment-control-dna-reactive-mutagenic-impurities-pharmaceuticals-limit_en.pdf›, cited 3 August, 2023.

Cited by 2 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Nitrosamine contamination of pharmaceuticals: Cases in Japan, formation mechanisms, detection methods, regulatory perspectives, and insights;Journal of Pharmaceutical and Biomedical Analysis Open;2024-12

2. Foreword;Chemical and Pharmaceutical Bulletin;2024-02-01