Stability studies

[#1]

Hi, Asking for ideas for analyzing data from a stability study with multiple compounds changing over time at different rates with many different types of samples included in the study.  Each data point is from a separate sample that has been aged for a given point in time.  Suggestions would be appreciated.

[#2 · Accepted solution]

I model stability of pharmaceutical products over time, based on conditions such as temperature and humidity (solids), or temperature and pH (liquids).  To do this I use the nonlinear platform (Analyze>Specialized Modeling>Nonlinear).

This approach does require that you know the functional form of the model.  This comes from domain knowledge and some understanding of  the mechanisms for degradation.  I use various modified forms of the Arrhenius equation (that are illustrated in the talk in the link below).

If you do a search, not just for 'this board' but across the entire community you will find a number of interesting presentations from past Discovery summits.

Here is one that I was involved with (it's custom code but behind the scenes it is the nonlinear platform):

https://community.jmp.com/t5/Discovery-Summit-Europe-2022/Predicting-Molecule-Stability-in-Biopharma...

[#3]

https://community.jmp.com/t5/Abstracts/Predicting-Molecule-Stability-in-Biopharmaceutical-Products-w...

If the link above doesn't work try this one :)