# Stability studies Data Variation

Hi,

What is long term or accelerated data show a) Little or no change over time b) little or no variability ?

What are these two things? How do i accesses these two parameters are with in the acceptance levels?

[quote=snagabiru]Hi,

What is long term or accelerated data show a) Little or no change over time b) little or no variability ?

What are these two things? How do i accesses these two parameters are with in the acceptance levels?[/quote]

Hi srikanth,

a)Little or No change means-Absolute value(Zero time point- 99.9).

Delta value is zero.
Eg:

Months assay
0 99.9
1 99.9
2 99.9
3 99.9
4 99.9
5 99.9
6 99.9
Here all the values over time are exactly no change with respect to absolute value. the net change(delta) is zero.

b)Litte or NO variability means- variation around the absolute value.

Months assay
0 99.9
1 100.1
2 99.8
3 99.9
4 99.8
5 99.9
6 99.8
Here there is a variability between absolute value and the values over time.

Second way of interpretation.
Some times we can understand like this.

Description and Limit tests are falls under a

Quantitation(Numerical values) tests falls under b

Best Regards,
Bujji Reddy Kanchi.
8008889185

Hi,

But if it is the case, Q1E Appendix, Step one is not applicable to any of the stability Data

Step 1: Tabulate and/or plot stability data on all attributes at all storage conditions and evaluate each attribute separately ---->

Significant change at accelerated condition within 6 months? -----No----->

Long- term data show: (1) little or no change over time and (2) little or no variability? ------- yes to both----->

Accelerated data show: (1) little or no change over time and (2) little or no variability? ------- yes to both----->

Statistical analysis is normally unnecessary

can u explain this ?

N.Srikanth

[quote=snagabiru]Hi,

But if it is the case, Q1E Appendix, Step one is not applicable to any of the stability Data

Step 1: Tabulate and/or plot stability data on all attributes at all storage conditions and evaluate each attribute separately ---->

Significant change at accelerated condition within 6 months? -----No----->

Long- term data show: (1) little or no change over time and (2) little or no variability? ------- yes to both----->

Accelerated data show: (1) little or no change over time and (2) little or no variability? ------- yes to both----->

Statistical analysis is normally unnecessary

can u explain this ?

N.Srikanth[/quote]

Hi,

It means the data over time shows no variation. hence statistical analysis is not required.

Statistical analysis is required only when the data shows variation.
hence we need extrapolation and risk assessment should be done. Since We have already given the retest date and commitment given such that stability study continues until retest covers.

How could step 1 is not applicable to any stability data ? can you please write in detail.

If it is possible to you, shall we discuss through phone. my number is 8008889185

Thanks and regards,
Bujji Reddy.