What inspired this wish list request?
For shelf-life estimation, Stability Analysis in the Degradation Platform commonly uses the different intercepts different slopes (DIDS) fixed-batch effects model to reflect inequality among batch slopes.
Therefore, it is important to improve the default method for estimating shelf life based on the DIDS model so that it is optimal.
Currently, the JMP Stability Analysis provides an inferior method (Individual MSE) as the default and a superior method (Pooled MSE) as an option. The two methods differ only in the variability estimate (i.e., mean square error (MSE)) utilized. In forming the confidence band about each batch, the default method forms the MSE using data variability from only an individual batch while the optional method constructs the MSE using data variability pooled across all batches.
Table 1 shows the comparative inferiority of the default Individual MSE method and the superiority of the optional Pooled MSE method. The default method does not follow the current ICH stability guidance (see also Table 2), but clings to using methodology in an outdated stability program based regulatory guidance withdrawn by FDA. Since it does not take advantage of a standard assumption of equal variance for the DIDS analysis of covariance (ANCOVA) fixed effects model, the default method forms relatively shorter estimates of shelf life (see also Figure 1). Because JMP is designed with scientists and engineers in mind, many users are likely to depend on the default procedure to serve them best. However, in this situation, the default Individual MSE method relatively speaking hinders users from achieving the goal of establishing their desired shelf life. Finally, the default Individual MSE method for the DIDS model represents a disconnect with the overall excellent standard of JMP tools and in this instance, a lag behind their competitors who have based their stability analysis methodology on ICH Q1E and good statistical practice.
What is the improvement you would like to see?
Only when descriptive data summaries / graphs suggest that the data have unequal variability about the individual batch regression lines, should the Individual MSE method be used. In that case, the method could be easily specified in JMP by using batch as a By Variable on the Stability Tab.
Why is this idea important?
Summary of Importance: Increased access to and ease of usage of improved statistical methodology to better meet the needs of users.
In the development of a pharmaceutical product, stability studies are time consuming, resource intensive, and very costly. Establishment of the desired shelf life is a critical milestone - even a “Go, No-Go” decision. Often the stability data analysis must be done in a compressed timeframe. It’s imperative to do the best data analysis that conforms to regulatory guidelines, quickly and easily, to maximize the opportunity to establish the desired shelf life. For the estimation of shelf life for the DIDS fixed-effects model, improving the default method to the Pooled MSE method will meet the needs and expectations of users and better position JMP compared to its competitors.
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Additional References
2024 JMP® 18 Reliability and Survival Methods. Cary, NC: JMP Statistical Discovery LLC
2025 JMP® Online Help. JMP Statistical Discovery LLC, Cary, NC
ICH Q1E Evaluation of Stability Data (June 2004)
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