Author:
Chen Dandan,Luo Lijun,Shen Dandan,Huang Li,Zeng Linggao,Wang Jianhua
Funder
Chongqing Plan for High Level Talents project of CQ CSTC
the National Major Scientific and Technological Special Project of the Ministry of Science and Technology of China
Publisher
Springer Science and Business Media LLC
Subject
Organic Chemistry,Clinical Biochemistry,Biochemistry,Analytical Chemistry
Reference22 articles.
1. FDA, CDER, M7 (R1) (2018) Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk guidance for industry. U.S. Department of Health and Human Services
2. EMA (2021) Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products, EMA/409815/2020 Rev.6
3. McGovern T, Jacobson-Kram D (2006) Regulation of genotoxic and carcinogenic impurities in drug substances and products. TrAC Trends Anal Chem 25(8):790–795
4. Muller L, Mauthe RJ, Riley CM, Andino MM, Antonis DD, Beels C et al (2006) A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity. Regul Toxicol Pharmacol 44(3):198–211
5. Giordani A, Kobel W, Gally HU (2011) Overall impact of the regulatory requirements for genotoxic impurities on the drug development process. Eur J Pharm Sci 43(1–2):1–15
Cited by
1 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