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

Raqeeb Jamil; James E Polli

doi:10.1016/j.ejps.2024.106745

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

Eur J Pharm Sci. 2024 May 1:196:106745. doi: 10.1016/j.ejps.2024.106745. Epub 2024 Mar 11.

Authors

Raqeeb Jamil¹, James E Polli²

Affiliations

¹ Department of Pharmaceutical Sciences, University of Maryland, 20 Penn Street, Baltimore, MD 21201, USA.
² Department of Pharmaceutical Sciences, University of Maryland, 20 Penn Street, Baltimore, MD 21201, USA. Electronic address: jpolli@rx.umaryland.edu.

PMID: 38471596
DOI: 10.1016/j.ejps.2024.106745

Abstract

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.

Keywords: Biorelevant; Bootstrapping; Dissolution; Ibuprofen; Ketoconazole; f(2).