Stability Analysis in JMP / FDA

Question

Hi all,

It would be of interest for some  of our customer to know whether we (at JMP)  have already received feedback from customers as to whether the standard Stability Analysis evaluation in JMP is accepted by the FDA.

Thank you in advance,

Cheers,

Valerie

SamGardner · Answer

Yes, the analysis in Reliability and Survival > Degradation is generally acceptable, in that it does perform the ICH Q1E shelf life calculations.

One thing to be aware of, however, is that since this feature was added, the Q1E guidance was updated to allow the analysis to use the pooled MSE in the situation of non-poolability of the stability batches.  The result of this is that if you use the pooled MSE, the calculated ICH shelf-life is longer, because the confidence interval for the regression line will be narrower.

Degradation does not currently use the pooled MSE, but instead treats the worst case stability batch as stand alone and calculates the regression confidence interval based solely on that single batch.  This is a known issue and development is aware of it, and may be addressing this in JMP 17.

karencopeland · Answer

Valerie,

From my experience (have worked on many diagnostic and/or device submissions to FDA) that is not a question you can answer. What is accepted is FDA is more complex than just the evaluation method. Also, every submission/review team is different. So there is no way to ever say something will or will not be accepted by FDA. Your customers need to follow FDA consensus guidance documents. JMP can provide analysis needed for FDA, that is true. The specific analysis of course depends on the product and study designs, etc.

Karen