Author:
van Wijk A.M.,Niederländer H.A.G.,van Ogten M.D.,de Jong G.J.
Subject
Spectroscopy,Environmental Chemistry,Biochemistry,Analytical Chemistry
Reference25 articles.
1. Committee for Medicinal Products for Human Use European Medicines Agency Guideline on the limits of genotoxic impurities, 2007.
2. Food and Drug Administration, U.S. Department of Health and Human Services: Center for Drug Evaluation and Research (CDER), Guidance for Industry: Genotoxic and Carcinogenic Impurities in APIs and Products, Recommended Approaches, 2008.
3. The application of structure-based assessment to support safety and chemistry diligence to manage genotoxic impurities in active pharmaceutical ingredients during drug development;Dobo;Regul. Toxicol. Pharmacol.,2006
4. A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity;Müller;Regul. Toxicol. Pharmacol.,2006
5. Control and analysis of alkyl and benzyl halides and other related reactive organohalides as potential genotoxic impurities in active pharmaceutical ingredients (APIs);Elder;J. Pharm. Biomed. Anal.,2008
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