Giordani, Antonio

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