A REVIEW OF METHODS USED TO COMPARE DISSOLUTION PROFILE DATA

In a number of recent guidance documents, the FDA has placed more emph asis on the meaningful comparison of dissolution profile data. For exa mple, the FDA scale-up and past-approval changes-modified release (SUP AC-MR) guidance indicates that similar dissolution profiles for approv ed and modified formulations is acceptable justification for certain l evels of change without prior FDA approval or the need to perform bioe quivalence studies, As a result, interest among pharmaceutical scienti sts has focused on the methodology that is available for the compariso n of dissolution profile data. The authors review the literature on th e methods that are currently available.