topic Re: Stability studies in Discussions

Stability studies

VarianceMink489 — Fri, 09 Jun 2023 00:53:48 GMT

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.

Re: Stability studies

David_Burnham — Thu, 18 Aug 2022 07:00:46 GMT

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-Biopharmaceutical-Products-with/ta-p/446141

Re: Stability studies

Michelle_Ricci — Sun, 13 Oct 2024 16:20:38 GMT

https://community.jmp.com/t5/Abstracts/Predicting-Molecule-Stability-in-Biopharmaceutical-Products-with/ev-p/755529

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