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
Module request: ICH Q1E stability analysis, shelf-life estimation and extrapolation
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Maged-Magdy
- Posts: 1
- Joined: Wed Jul 01, 2026 12:20 pm