Bioequivalence and Bioavailability Forum

Dear All,

In FDA guidance for dissolution profile comparison we could find other method than similarity factor. If within batch variation is more than 15%CV we could use multivariate model independent procedure for dissolution profile comparison. Could anyone give the explanation about?

1. How to calculate the similarity limits in terms of multivariate statistical distance (MSD) based on interbatch differences in dissolution from reference batches?
   
2. How to estimate 90% confidence interval of true MSD between test and reference batches.

Any possible softwares are used to do this calculation plz post it soon.


Thanks.

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Edit: Category and subject line changed. [Jaime]