What inspired this Wish List Request?
JMP has the brilliant feature of Stability analysis regarding ICH Q1E. But the shelf life prediction value per batch is not provided.
MFDS(Korean FDA) announced to my new customer, YuHan which is top 3 pharmaceutical company in South Korea especially chemical products that they(YuHan) should show each predicted shelf life value in the output of Stability Analysis.
Please describe the new or improved feature or solution you would like to see.
Minitab provides each predicted value of shelf life like below.
Example of Stability Study with a fixed batch factor
I already asked JMP Tech Support and received the answer for no possible feature for printing each predicted value.
Of course, my customer and I already knew the feature for Save Crossing Time in inverse prediction's RTM like below.
But my customer and MFDS, Korean regulatory agency did not want to reproduce results via any further manipulation.
They want
1. printed predicted shelf life value in JMP output like Minitab.
or
2. print the predicted value in the above graph which can be captured the results easily.
What would the value be to you and/or other users if this new feature is provided?
Of course, this feature is not big deal for stability analysis, but if the regulatory agency wants this, almost every pharma company should follow this.
Is this an external customer request?
Yes, as I wrote earlier, YuHan pharma company wants this feature, and the customer name would be SuHyeon Kim(saengg7@yuhan.co.kr).
Is there a competitive software package that has this feature or solution that we should be aware of?
Minitab's stability analysis
Will this impact a renewal, expansion, or adoption at a customer, and does this put an account at risk if we do not address this?
One of the customers in YuHan said that if there's no this feature in JMP, they have no need to use JMP any more.
