topic Re: How do I perform Stability predictions? in Discussions

How do I perform Stability predictions?

RevathiT — Sat, 10 Jun 2023 23:25:33 GMT

I am tracking the stability of a pharmaceutical drug product to determine the shelf-life. I have the assay data for initial (T=0), 1 month, 2 month. Can I predict the assay for 3 months?

Re: How do I perform Stability predictions?

P_Bartell — Tue, 02 Feb 2021 15:33:28 GMT

You can find stability analysis capabilities in the JMP online documentation here Stability Analysis in JMP .

Re: How do I perform Stability predictions?

Byron_JMP — Tue, 02 Feb 2021 15:48:46 GMT

Short Answer, yes, maybe.

What would be pretty phenomenal is if you had several batches on stability, and you could pool them. ICH Q1E talks about this process, and luckily, it's easy to do in JMP.

The trouble with having just 3 data points, is that the confidence interval will be large so, your calculated expiry date is going to be conservatively short.

If you have time, take a look at this talk:

https://www.jmp.com/en_gb/events/ondemand/technically-speaking/pharmaceutical-product-stability/watch.html#formsuccess

It explains how to calculate expiry in more detail along with the stats.

Re: How do I perform Stability predictions?

RevathiT — Tue, 02 Feb 2021 17:33:16 GMT

Thank you for sharing about this tool and this is helpful.

Re: How do I perform Stability predictions?

RevathiT — Tue, 02 Feb 2021 17:34:00 GMT

This is helpful, thank you for sharing.