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JMP stability test report questions

stability test data  as follow:

Using the  degradation>Stability test Platform，result for response，date for time，lot for label，Enter 0.012 for the uper Spec Limit and

click ok.

Q1：The report shows  different· slope and different intercepts，but the chart（shows as follow left）didn't choose the most shorter date for the expiration date（according to the ICH) ，why?

Q2：What is the meaning for the "source A ".？

Q3：According to JMP report ，the expiration date is 133 ，on the other hand ，i use minitab 17 “Stability test Platform”to  forecast  the same data ，it also concludes that different· slope and different intercepts is given and the expiration date is 94（shows as follow right），what is different between jmp and minitab in the Stability test Platform？

 

 

Re: JMP stability test report questions

Hi Phil_Kay, I recently got a report from my CMO stating the predicted shelf life from JMP stability test program as 14 months that is very low. I analysed the input data of 4 batches and found that there was high varibility in the data to the extent that I can call it haphazard. (attaching a snapshot of the regression plot). "Garbage in leads to garbage out". Canyou please guide me on " how reliable is output when the input data is like this as depicted in the plot". Also how do I access the significance of this model. I mean how do we access that the model is valid enough to be able to predict the shelflife. 

 

Re: JMP stability test report questions

Hi,

 

I suggest you contact technical support (email: support@jmp.com).

 

I ran your analysis from your table and got the results that I had got previously.

 

Regards,

Phil

Re: JMP stability test report questions

This is my analysis.the expiration date "133"is a automatical result from reports.

Re: JMP stability test report questions

My data table and analysis attached.

Re: JMP stability test report questionsI can't reproduce your result.

I get "The best model accepted at the significance level of 0.25 has Different intercepts and Different slopes. The model suggests the earliest crossing time at 57.03571 with 95 percent confidence. ICH Guidelines indicate an expiration time of 57.03571."

Maybe you save your script to the data table and attach the data table in a reply in this discussion.

Or you could send the data table and your questions to support@jmp.com.

Regarding Q2: Briefly, Source A is explained in the legend. It is part of the model comparison between the different possible models (as per ICH).