Predict Shelf Life of pharmaceutical products

[#1]

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

[#2]

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.

[#3]

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.

[#4]

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.

[#5]

Thank you

[#6]

That video is also helpful.