topic Re: Predict Shelf Life of pharmaceutical products in Discussions

Predict Shelf Life of pharmaceutical products

traihan — Sat, 10 Jun 2023 20:43:52 GMT

Hi All

Need a little bit of help. Need to predict shelf life of a drug product. What kind of data should I need to generate?

Can generate stability data (assay and may be imp) for Intermediate temp for 6 mon and Acc temp for 3/6 mon. Room temp stability is too long. Don't have that much time. How do I use JMP to determine shelf life from Int or Acc stability data?

Obviously, I searched the JMP help and the community, did not find information that was helpful to me.

Thanks in advance

Re: Predict Shelf Life of pharmaceutical products

Mark_Bailey — Fri, 19 Mar 2021 16:39:20 GMT

Most users follow the ICH Q1A and Q1E guidance documents for how to plan a stability test and evaluate the data.

JMP implements the evaluation as the Stability Analysis in the Degradation reliability platform.

Re: Predict Shelf Life of pharmaceutical products

traihan — Sat, 20 Mar 2021 00:05:23 GMT

Thank you Mark. It seems like the data is based on room temperature.

I need to use degradation data from elevated temperature (and humidity) - use arrhenius equation.

Re: Predict Shelf Life of pharmaceutical products

Mark_Bailey — Sat, 20 Mar 2021 11:53:27 GMT

Start reading earlier in the chapter that explains the Degradation platform. You want to use the Repeated Measures analysis instead of the Stability Test analysis.

Start reading here.

Re: Predict Shelf Life of pharmaceutical products

traihan — Mon, 22 Mar 2021 13:33:51 GMT

Thank you

Re: Predict Shelf Life of pharmaceutical products

Ressel — Thu, 25 Mar 2021 19:59:39 GMT

That video is also helpful.