有一些不錯的Decision Tree! ANDAs: Impurities in Drug Products [HTML] or [Word] or [PDF] | Draft | 8/26/2005 |
ANDA's: Impurities in Drug Substances [HTML] or [PDF] | Final | 11/1999 |
ANDAs: Impurities in Drug Substances [HTML] or [Word] or [PDF] | Draft | 1/28/2005 |
ANDAs: Pharmaceutical Solid Polymorphism [HTML] or [Word] or [PDF]. | Draft | 12/17/2004 |
2006/6/18
ANDA (Draft) Guidance - Impurities and Polymorphism
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