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pharmaceutical stability assessment

nac

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.

Stability assessment template.jmp

Accepted answers

Mark_Bailey

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.

Stability Assessment per ICH E10 Template.jmp

All comments

nac

Is there anyone have any idea about this?

Mark_Bailey

Stability Assessment per ICH E10 Template.jmp

Mark_Bailey

Is there any response to the answer?

nac

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

Best Regards,