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Pharmaceutical impurities: regulatory perspective for Abbreviated New Drug Applications

Arup K Basak1, Andre S Raw, Ali H Al Hakim

  • 1Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, USA. arup.basak@fda.hhs.gov

Advanced Drug Delivery Reviews
|January 2, 2007
PubMed

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