Shelf Life - Stability Studies
FDA links to guidance on stability
-- tbd --
STABILITY Guidelines
Note on May 5, 2011:
The links below were created before ICH redesigned their website. I'll fix them later. For now, here is a link that should lead to the ICH information. http://www.ich.org/products/guidelines/quality/quality-single/article/evaluation-of-stability-data.html
May 2014: Links are updated.
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