Scribd
Upload
13 views

Stability Matrixing

Uploaded by

quality.euploid
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
13 views

Stability Matrixing

Uploaded by

quality.euploid
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 1

Matrixing is a method used to reduce the number of samples tested in stability

studies for pharmaceutical products. It's a design technique that allows for
testing a subset of all possible combinations of factors at each time point.
How it works
 A matrixed stability study tests a subset of samples at each time point,
but tests all combinations over the entire study
 The study design assumes that the stability of the tested samples
represents the stability of the remaining samples at a given time point
 The study design can be extended to multiple product presentations or
storage conditions
Benefits
 Matrixing can reduce the amount of testing required, which can save time
and money
 It can also reduce the amount of space needed to store samples
Considerations
 Matrixing designs may have less precision in shelf life estimation
 Matrixing designs may not have enough power to detect certain effects
 Matrixing designs may yield a shorter shelf life than a full design
Related methods
 Bracketing: A related method that involves testing certain combinations
of factors, assuming that the stability of the items in between will follow a
known pattern

You might also like