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pharmaceutical stability assessment

nac

Occasional Contributor

Joined:

Feb 17, 2017

Dear all,

I try to apply stability assessment according to ICH E10 stability guidance "5% change from initial value is a significant change"

I have 3 different strength (10, 20, 50) and each streght include 3 batch(Batch 1, Batch 2, Batch 3). Each batch have 3 stability condition (25/60, 30/65, 40/75) each condition have different timepoints. 

I try to determine the percentage change of result from initial timepoint for each batch and condition is greater or lower than 5%. 

and also the percentage change of results from previous timepoint for each batch and condition is greater or lower than 5%. 

 

Is there anyone can help for this? 

You can see my template at the attachment. 

 

 

1 ACCEPTED SOLUTION

Accepted Solutions
markbailey

Staff

Joined:

Jun 23, 2011

Solution

I am very busy at the moment but I was able to set up data columns with formulas for the assessment of the Result per your description. I do not have time to test it so please enter data and see if it works as needed.

Learn it once, use it forever!
4 REPLIES
nac

Occasional Contributor

Joined:

Feb 17, 2017

Is there anyone have any idea about this?

markbailey

Staff

Joined:

Jun 23, 2011

Solution

I am very busy at the moment but I was able to set up data columns with formulas for the assessment of the Result per your description. I do not have time to test it so please enter data and see if it works as needed.

Learn it once, use it forever!
markbailey

Staff

Joined:

Jun 23, 2011

Is there any response to the answer?

Learn it once, use it forever!
nac

Occasional Contributor

Joined:

Feb 17, 2017

Thank you for your help. It is a solution for my problem.

 

Best Regards,