Author:
Zawatzky Kerstin,Lin Mingxiang,Schafer Wes,Mao Bing,Trapp Oliver,Welch Christopher J.
Funder
Merck Research Laboratories Department of Process Research & Development
Subject
Organic Chemistry,General Medicine,Biochemistry,Analytical Chemistry
Reference36 articles.
1. EMEA-CHMP, EMEA/CHMP/QWP/251344/2006 London (June, 2006).
2. Strategies for the identification, control and determination of genotoxic impurities in drug substances: a pharmaceutical industry perspective;Raman;J. Pharm. Biomed. Anal.,2011
3. A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity;Müller;Regul. Toxicol. Pharmacol.,2006
4. International Conference on Harmonization, ICH M7 (Step. 4): Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk (ICH, Geneva, Switzerland, May 2015).
5. Strategies to address mutagenic impurities derived from degradation in drug substances and drug products;Kleinman;Org. Process Res. Dev.,2015
Cited by
5 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