2006/6/18

ANDA (Draft) Guidance - Impurities and Polymorphism

有一些不錯的Decision Tree!

ANDAs: Impurities in Drug Products [HTML] or [Word] or [PDF]

Draft8/26/2005
ANDA's: Impurities in Drug Substances [HTML] or [PDF] Final11/1999
ANDAs: Impurities in Drug Substances [HTML] or [Word] or [PDF] Draft1/28/2005
ANDAs: Pharmaceutical Solid Polymorphism [HTML] or [Word] or [PDF]. Draft12/17/2004

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