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Use of Statistics to Establish a Stability Trend: Matrixing

  • Earl Nordbrock
Chapter
Part of the Biotechnology: Pharmaceutical Aspects book series (PHARMASP, volume XII)

Abstract

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.

Keywords

Shelf Life Stability Study Matrix Design Lower Confidence Confidence Bound 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Copyright information

© American Association of Pharmaceutical Scientists 2010

Authors and Affiliations

  1. 1.Nordbrock ConsultingDraperUSA

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