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liliconcom

pharmaceutical stability assessment

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.

Re: pharmaceutical stability assessment

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

Best Regards,

Re: pharmaceutical stability assessment

Is there any response to the answer?

Re: pharmaceutical stability assessment

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.