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Shelf Life - Stability Studies


 
FDA links to guidance on stability
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ICH Quality Guidelines
 

STABILITY Guidelines

Note on May 5, 2011:  

Q1A (R2)     Stability Testing of New Drug Substances and Products
Q1B            Stability Testing: Photostability Testing of New Drug Substances and Products
Q1C            Stability Testing for New Dosage Forms
Q1D            Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
Q1E            Evaluation of Stability Data
Q1F            Stability Data Package for Registration Applications in Climatic Zones III and IV



 
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