what is the Bracketing & Matrixing.
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Answer / sirisha
Bracketing: is the design of a stability
schedule such that only samples on the extremes of certain design factors (e.g., strength,
container size and/or fill) 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.
Matrixing: is the design of a stability
schedule such that a selected subset of the total number of possible samples for all factor
combinations would be tested at a specified time point. At a subsequent time point, another
subset of samples for all factor combinations would be tested. The design assumes that the
stability of each subset of samples tested represents the stability of all samples at a given time
point.
| Is This Answer Correct ? | 46 Yes | 6 No |
Answer / 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
| Is This Answer Correct ? | 14 Yes | 2 No |
Answer / vikram
Answer 4 is correct answer and great detail of matrixing and bracketing is available in ICH Q1D guideline of stability data analysis
| Is This Answer Correct ? | 5 Yes | 2 No |
Answer / a s n kumar (makson industri
.Both Matrixing & Bracketing’s are reduced stability testing designs
Bracketing
The design of a stability schedule, such that only samples of extremes of certain design factors (ex:strength,package size) are tested at all time points as in full design.The designs assumes that the stability of any intermediate level is represented by the stability of extremes tested.
Matrixing
The design of a stability schedule, such that a selected subset 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 combination is tested.The design assumes that the stability of each subset samples tested represents the stability of all samples at a given time point.
There for a given time point other than initial & final ones not every batch on stability needs to be tested.
| Is This Answer Correct ? | 5 Yes | 2 No |
Answer / suresh palacharla
Bracketing means we vl do analysis only extemes of strengths
and packaging modes.Bracketing we can see mostlly in
formulation units.
Matrixing means we vl do analysis each and every strength in
every interval.
| Is This Answer Correct ? | 7 Yes | 7 No |
Answer / deepak kumar
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.
| Is This Answer Correct ? | 0 Yes | 0 No |
Answer / sumit palta
its not about system suitability check .its about stability program in formulated drug product by following the ich guideline Q1D.
| Is This Answer Correct ? | 10 Yes | 16 No |
Answer / kishore
Bracketing is doing standard injection after every 3
batches to know the performance of the system middle of the
analysis.
| Is This Answer Correct ? | 18 Yes | 30 No |
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