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Using Multiple Time Point Dissolution Specifications with Models

I have a stacked table with a Time Point (X) column, a Cumulative Release (Y) column, and several columns of factors from a DOE. We have different specification limits for release at various time points in the dissolution curve, as required by the FDA. In development, I need to fit curves to the data, use models to determine significant factors, and optimize factors using Desirability Functions. I can fit curves with this table, but I cannot use the Desirability Functions because each column can only have one set of specifications saved with it. I can split the table by Time Point and make a new table, but that creates more documentation and review work, as required by our data integrity rules. It would be nice if there was a way to account for these specifications in Fit Model and FDE.

 

Suggestions

 

  • Allow specification limits to be set conditionally. This may help resolve the problem for non-FDE models.

 

  • In FDE, allow more than one target curve. Curves based on upper spec, target, and lower spec would allow explorations of the variable space for each target curve.

I use JMP Pro 16.2.0

2 Comments
Sarah-Sylvestre
Level V
Status changed to: Acknowledged

@Charlie - Thank you for your suggestion! We have captured your request and will take it under consideration.

@Charlie i would have a workaround for this problem

Do a DOE for each run, one particular batch, different columns would be the dissolution at different time point with specifications, the data set should look like that: 

Valerie_Nedbal_0-1748272572222.png

Do a model using the fit model an use maximize desirability function

Valerie_Nedbal_1-1748272882386.png

In such you will find the best combination of your factors that will set your dissolution curve on target. Would that help?