bootf2BCA v1.5 - ICH M13B edition
Copyright (C) 2016-2026 Aleksander Mendyk
This program is distributed "AS IS" in the hope that it will be useful, but WITHOUT ANY WARRANTY;
without even the implied warranty of MERCHANTABILITY or FITNESS FOR A PARTICULAR PURPOSE.
See the GNU General Public License (LICENSE.txt) for more details.
Full documentation: Documentation_bootf2BCA_v1.5.pdf
WHAT IS NEW IN v1.5 (all changes in the R code are marked with the comment "# M13B")
* Median of the bootstrapped f2 and the ICH M13B acceptance criterion:
lower bound of the two-sided 90% bootstrap CI >= 46 AND median >= 50
(evaluated for every CI type; percentile CI is the default primary type)
* New cut-off rule 3 "ICH M13B" (default): zero time point excluded; last time point = first point
with >=85% dissolved for EITHER profile, or first point of the plateau reached by BOTH profiles
(3 successive points differing by <=5%); at least 3 points; warning if more than 6 points
* Time points fixed from the original mean profiles (default) or re-selected per bootstrap sample
* Decision-tree pre-assessment (ICH M13B Figure 1): units >=12, very rapid/rapid dissolution,
plateau <10%, SD <=8% (conventional f2) vs SD >8% (bootstrap)
* New GUI tab "M13B pre-assessment", median in results/histogram, ICH M13B section in the report
* ICH M13B analysis is performed automatically only with cut-off rule 3; rules 0-2 give v1.4-style
results (check box "ICH M13B analysis" / argument m13b_analysis to override). GUI section renamed
"Dissolution profile cut-off rules".
* Flet edition (recommended): native desktop GUI built with Flet (Flutter, Material 3) - Linux
single-file executable;
* Web stand-alone edition: self-running executables (Windows, Linux, macOS) with a GUI in the browser,
numerically identical to the R edition (same seed -> same bootstrap samples -> same CIs)
DIRECTORIES
GUI/ Shiny GUI (R) - run run_shiny.R (or shiny::runApp() in this directory)
CLI/ command-line script (R) - edit and run bootf2BCA_v1.5.R
flet/ Flet edition (main.py GUI+CLI, bootf2_engine.py, tests, build_linux.sh, CI workflow)
standalone/ Go source of the web stand-alone edition (build.sh builds all platforms)
validation/ R vs stand-alone validation (36 configurations, identical results)
R REQUIREMENTS: boot, shiny, shinyFiles, plotly (install_prerequisites.R)
STAND-ALONE EDITION: no requirements; see bootf2BCA_v1.5_binaries.zip
CITATION
Aleksander Mendyk, Adam Paclawski, Jakub Szlek, Renata Jachowicz. PhEq_bootstrap: an Open Source
software for simulation of f2 distribution in cases of a large variability in the dissolution profiles.
Dissolut Technol, 20(1), 2013, 13-17.
