Module request: ICH Q1E stability analysis, shelf-life estimation and extrapolation

[Maged-Magdy]

I would like to suggest a module for pharmaceutical stability analysis following ICH Q1E. I have not found a module covering this workflow. Is one available or under development?
Suggested functionality:
- Import time, batch and quantitative results, with user-defined specification limits.
- Fit regression models and provide model diagnostics.
- Assess batch poolability using ANCOVA: test slopes first, then intercepts where appropriate, using α = 0.25.
- Support the three resulting models: separate slopes and intercepts; a common slope with separate intercepts; or a common slope and intercept. Where slopes differ, use the pooled residual mean square error across batches. Where batch-specific estimates remain, report the shortest.
- Estimate shelf life/retest period from the earliest intersection of the appropriate 95% confidence bound for the mean with a specification limit: lower one-sided for decreasing attributes, upper one-sided for increasing attributes, and two-sided when direction is unknown.
- Distinguish the statistical estimate from the extrapolation permitted under the applicable ICH Q1E conditions and Appendix A decision tree.
- Provide plots and exportable results.
Future extensions could support multifactor studies, using α = 0.25 for batch-related terms and α = 0.05 for non-batch-related terms.
This would help pharmaceutical QC and stability researchers use jamovi for a complete stability evaluation workflow.
Would any module developers be interested in implementing this or extending an existing module?
Reference: ICH Q1E — Evaluation of Stability Data

[yurismol]

I can give it a try

[yurismol]

You can test and critique the first attempt (Stability Analysis ICH Q1E).
https://github.com/yurismol/jYS/release ... _1.2.0.jmo

Sample dataset included into the module.
Description: https://github.com/yurismol/jYS/release ... iption.pdf

[yurismol]

A new version of the jYS module (1.2.0), featuring stability analysis, is now available in the Jamovi library.

[Maged-Magdy]

Thank you very much for taking this on, and for the quick turnaround. I’m glad to see the stability analysis now available in jYS 1.2.0.

I’ll install it from the Jamovi library, test it with the sample dataset and with real stability data, and share my feedback (results, any discrepancies, and suggestions) here soon.

Thanks again for your time and effort, this will be a valuable addition for pharmaceutical QC and stability researchers using jamovi.