Random Batch Shelf Life / Stability Analysis

[#1]

Purpose

This add-in uses JMP mixed model platform to do stability / shelf-life analysis while considering random batches.  Statistical details for the analysis are found here: Mixed model stability analysis

Walkthrough

Support

JMP Version: JMP Pro 17 or newer

Operating System: Windows or MacOS

Notes

13Nov2024: Updated Add-in to correct a small issue with the displayed equation under the envelop setting.

[YinHoongMok]

Hi Mike, thanks for the nice add-in. However, there's a line indicating that there are reported errors in my graphics scripts. Can you help me on this? 

[Alex_Xu]

Hi Mike,

Thanks for sharing the add-in, some of Greater China's pharma customers are very interested in it and I've tried using it myself.

Since I felt that the variance components of some of the random effects terms were strange in some of the dataset tests, I looked at the settings for the mixed model launching platform.

The current random effects settings in this add-in are as follows, intended to assess different batches of drugs with different degradation intercepts and slopes.

This may have the same intent as the following settings, but the resulting variance components may not be the same, leading to different estimates of shelf life.

I wonder if there are any relevant notes or considerations in the literature you referenced as to which setting makes more sense?

Thanks again for the great sharing!

[MikeD_Anderson]

@Alex_Xu - since I'm not actually calculating the components, you might want to put that into tech support. The blog I wrote on how the add-in works and which parts I actually wrote is linked at the top of the page. 

[Alex_Xu]

@MikeD_Anderson  - Thanks to your reminder, I have searched the literature on the relevant methodology as well as the different considerations.

[stoneC]

HI Mike,

I have JMP v18.  I run into following issue when launch this add-in.  can you help?  Thanks a lot.

[MikeD_Anderson]

@stoneC - at a guess it might not have installed correctly.  I’d try reinstalling it.  It also requires JMP Pro, and that might trigger an error if you’re trying to run it on base JMP.  

m

[stoneC]

Hi Mike,

Thanks for the reminder.  This time, I use JMP Pro 18.  I see the JMP Alert below.  

In my analysis, I did not see the session "Random Batch Shelf Life Determination" like you shown in your video.  Can you tell me how to turn on that session.

Thanks a lot.

Stone

[MikeD_Anderson]

@stoneC - can you share a screenshot of what it looks like when you first start the add-in with the columns filled in (i.e. before you click OK to launch the analysis).  Also could you share a screenshot of what the columns and the first couple of rows of data look like?

M

[stoneC]

Hi Mike,

Thanks for the help.  Please see the screen shoots below.

Regards,

Stone

 

[MikeD_Anderson]

Okay - going to document this here.  It looks like the problem is that the search algorithm is failing due to some noise in the data set.  The good news is that this issue is corrected in JMP Pro 19.