Home Forums General Discussion Can bracketing/matrixing be applied to Product having different pack sizes?

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  • John O’Neill
    Post count: 75
    (Question posted for an industry colleague)
    Yes, and you can find specific information in the Guidance for Industry Q1D, Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products. In addition, there is an excellent article by Ray Munden entitled The Role of Bracketing and Matrixing in Efficient Design of Stability Protocols, December 1, 2005, Pharmaceutical Technology Europe-12-01-2005, Volume 17, Issue 12.
    As always, before proceeding, consult your Regulatory Affairs colleagues to gain advance approval of your plan by the appropriate Regulatory Body.
    StabilityHub welcomes additional comments and your Bracketing/Matrixing experiences to be posted on this thread.
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