Overall impact of the regulatory requirements for genotoxic impurities on the drug development process. [electronic resource]
- European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences May 2011
- 1-15 p. digital
Publication Type: Journal Article; Review
1879-0720
10.1016/j.ejps.2011.03.004 doi
Animals Chemistry, Pharmaceutical DNA Damage Drug Contamination--legislation & jurisprudence Drug Industry--standards Europe Guidelines as Topic Humans International Cooperation Mice Mutagens--analysis Pharmaceutical Preparations--analysis Quality Control Risk Assessment Toxicity Tests--standards United States United States Food and Drug Administration