In the Fit Curve platform, a model-free comparison report is created when one of the three model-free comparison techniques is used: F1 Analysis, F2 Analysis, or Multivariate Distance. The report title corresponds to the name of the method. Each model-free comparison report contains a tabbed report of curve comparisons. If there are multiple test groups, each model-free comparison report contains a summary table. There is also a note at the top of each report that indicates which level of the grouping variable was used as the reference group.
The summary table has a row for each test group that is being compared to the reference group. There are columns for the observed factor value and the lower and upper confidence limits for the corresponding method (F1 Analysis, F2 Analysis, or Multivariate Distance). For the F2 Analysis and Multivariate Distance options, the summary table also contains a conclusion column that indicates whether the test curve for that row is similar or not similar to the reference curve.
The Comparisons section contains a tab for each test group that is being compared to the reference group. Each tab contains a plot, table of values, and a table of results for the specified technique. If the F1 Analysis or F2 Analysis technique is used, a plot of bootstrap results is also shown.
The plot shows the two mean dissolution curves, as well as the individual replicate curves. The curves are colored according to whether they came from the Reference batch or a Test batch. There is also a table of summary statistics that provide the mean, standard deviation, and coefficient of variation (CV) for each time point for both the reference group and the test group. If a value is highlighted yellow in the table of summary statistics, one of the following conditions is true:
• The test group has more than one time point with a mean dissolution greater than 85%.
• The first time point in the test group has a CV value that is greater than 20%.
• There is a time point after the first time point in the test group that has a CV value that is greater than 10%.
If the F1 Analysis or F2 Analysis technique is used, the table of results is from the bootstrap procedure. The table includes the observed F1 or F2 value, the number of bootstrap samples, the bootstrap mean, the bootstrap median, the lower and upper BCa confidence limits, and the skewness and kurtosis. There is also a conclusion section for the F2 Analysis. The Bootstrap Results section contains the value of F1 or F2 for each bootstrap sample and a normal quantile plot of the bootstrap samples.
If the Multivariate Distance technique is used, the table includes the observed Mahalanobis distance value, the calculated lower and upper confidence limits, and maximum difference. The maximum difference is what the Mahalanobis distance would be if the difference between the reference tablet and test tablet was 10% at every time point. See Statistical Details for Dissolution Curve Analysis. If the upper limit for M is less than the maximum difference, then the conclusion is that the dissolution of the test tablet is similar to the dissolution of the reference tablet.
The red triangle menu for the F1 Analysis, F2 Analysis, and Multivariate Distance reports contain the following options:
Curve DOE Analysis
(Available only if a grouping variable and at least one supplementary variable are specified in the launch window. The grouping variable must contain at least five levels. Not available if the Columns as Functions format is used.) Launches a Generalized Regression report within the model-free comparison report to model the corresponding factor (F1, F2, or Multivariate Distance) as a function of the supplementary variables. See Curve DOE Analysis.
Save Bootstrap Results
(Available only for F1 Analysis and F2 Analysis.) Saves columns to a new data table. The new data table contains the bootstrap results from either an F1 or an F2 analysis.
Remove Fit
Removes the model-free comparison report from the Fit Curve report.