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ANDAs: Stability Testing of Drug Substances and Products

By David Lim posted 07-Jul-2014 09:53

  

There are two guidances available concerning Generics' Stability Testing of Drug Substances and Products.
FDA Guidance for Industry ANDAs: Stability Testing of  Drug Substances and Products

June 2013

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FDA Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products: Questions and Answers

May 2014

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Download IEC standards
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