Application of bootstrap f2 to dissolution data from biorelevant media and evidence of the conservative nature of bootstrap f2

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 dissol...

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Bibliographic Details
Published in:European journal of pharmaceutical sciences 2024-05, Vol.196, p.106745-106745, Article 106745
Main Authors: Jamil, Raqeeb, Polli, James E.
Format: Article
Language:English
Subjects:
Biorelevant
Bootstrapping
Dissolution
Ibuprofen
Ketoconazole
Online Access:Get full text
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Summary: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. [Display omitted]
ISSN:0928-0987
1879-0720
DOI:10.1016/j.ejps.2024.106745