Use of Statistics to Establish a Stability Trend: Matrixing

Part of the Biotechnology: Pharmaceutical Aspects book series (PHARMASP, volume XII)


Guidance Q1E gives several options for calculating shelf life. These options are compared using examples. Bracketing and matrixing (Guidance Q1D) are the ways to reduce the amount of testing in a stability study. Examples of matrixed and bracketed designs are presented, and the probabilities of obtaining a given shelf life for the reduced designs are compared to the same probabilities for the full design.


Shelf Life Stability Study Matrix Design Lower Confidence Confidence Bound 

Copyright information

© American Association of Pharmaceutical Scientists 2010

Authors and Affiliations

  1. 1.Nordbrock ConsultingDraperUSA

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