TY  - GEN
AU  - Giordani,Antonio
AU  - Kobel,Werner
AU  - Gally,Hans Ulrich
TI  - Overall impact of the regulatory requirements for genotoxic impurities on the drug development process
SN  - 1879-0720
PY  - 2011///0930
KW  - Animals
KW  - Chemistry, Pharmaceutical
KW  - DNA Damage
KW  - Drug Contamination
KW  - legislation & jurisprudence
KW  - Drug Industry
KW  - standards
KW  - Europe
KW  - Guidelines as Topic
KW  - Humans
KW  - International Cooperation
KW  - Mice
KW  - Mutagens
KW  - analysis
KW  - Pharmaceutical Preparations
KW  - Quality Control
KW  - Risk Assessment
KW  - Toxicity Tests
KW  - United States
KW  - United States Food and Drug Administration
N1  - Publication Type: Journal Article; Review
UR  - https://doi.org/10.1016/j.ejps.2011.03.004
ER  -