f2 with or without bootstrapping is the most common method to compare in vitro dissolution profiles, but methods to compare dissolution profiles have become less harmonized. The objective was to compare outcomes from bootstrap f2 and f2 (i.e. not-bootstrapped f2) using a large set of in vitro dissolution data. Non-parametric bootstrapping was performed on the 104 profile comparisons that did not meet the percent coefficient of variation (CV%) criteria to use average dissolution data. Bootstrap f2 was taken as the lower 90 % confidence interval of bootstrapped samples. There was concordance between bootstrap f2 and f2 in 92 of the 104 comparisons (88 %). There were no false positives. However, 12 % were false negative. Inspection of these discordance pairs suggests that bootstrap f2 serves as a conservative approach to assess profile similarity, particularly when a value of 50 is being used as decision criteria.

Dissolution

Biorelevant

Bootstrapping

f2

Ibuprofen

Ketoconazole

coefficient of variation

Biopharmaceutics Classification System

Food and Drug Administration

European Medicines Agency

United States Pharmacopeia

fasted-state simulated gastric fluid

fed-state simulated gastric fluid

fasted-state simulated intestinal fluid version 2

fed-state simulated intestinal fluid version 2

revolutions per minute

Data will be made available on request.

© 2024 The Authors. Published by Elsevier B.V.