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Comparing Dissolution Curves Hands-On Activities and Solutions

This activity can stand alone and also is a companion activity to the Mastering JMP session Characterizing and Comparing Dissolution Profiles for New Drug Formulations.

 

This hands-on activity allows you to practice comparing the shape of dissolutions curves over two groups. Instructions are below and in the attached PDF, which also contains the solutions. The data table is also attached to this post.

 

Suppose you are interested in the dissolution of your new tablets using a new coating. You coat ten tablets with the new coating (Treatment) and ten tablets with the usual coating (Control). You would like to compare the shape of the curve of % Dissolved over time between the two groups. The data are in the Dissolution.jmp data table.

Answer the following questions:

  1. Using F2 analysis, are the dissolution curves determined to be similar or not similar?
  2. Fit a variety of parametric models, pick the best model using AICc, and use equivalence testing to compare groups using the default decision limits. Which dissolution curve parameters are equivalent or not equivalent?

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