what is the Bracketing & Matrixing.
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Answer Posted / patel riken
Bracketing :
The design of a stability schedule such that only samples
on the extremes of certain design
factors, e.g., strength, package size, are tested at all
time points as in a full design. The design
assumes that the stability of any intermediate levels is
represented by the stability of the
extremes tested. Where a range of strengths is to be
tested, bracketing is applicable if the
strengths are identical or very closely related in
composition (e.g., for a tablet range made
with different compression weights of a similar basic
granulation, or a capsule range made by
filling different plug fill weights of the same basic
composition into different size capsule
shells). Bracketing can be applied to different container
sizes or different fills in the same
container closure system.
Matrixing :
The design of a stability schedule such that a selected
subset of the total number of possible
samples for all factor combinations is tested at a
specified time point. At a subsequent time
point, another subset of samples for all factor
combinations is tested. The design assumes that
the stability of each subset of samples tested represents
the stability of all samples at a given
time point. The differences in the samples for the same
drug product should be identified as,
for example, covering different batches, different
strengths, different sizes of the same
container closure system, and, possibly in some cases,
different container closure systems.
thanks
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