PhEq_bootstrap v 1.2 Copyright (C) 2014 Aleksander Mendyk <email@example.com>
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 for more details.
This program was developed as a help in establishing pharmaceutical equivalence by use of FDA f2 coefficient. It was designed to help with f2 computation in cases when intra- and inter-batch variability is large, namely RSD>10%. The use of statistical bootstrap technique allows to implement confidence interval (CI) into the f2 coefficient resulting in overcoming of their major drawback in the original metrics. The algorithm provides possible “worst case scenario” of f2 value, thus supporting claim about pharmaceutical equivalence. The target users are researchers from industry and academia dealing with pharmaceutical equivalence problem.
The software is Open Source. It was developed in Lazarus environment, therefore source code is available in ObjectPascal.
2. How to start?
There is no need to install the software - both for Linux and Windows environments. Simply unpack the archive and run the application. Software does not write anything in any of the system-sensitive places (win-registry or lin /etc)
You have to push 4 buttons on the Main tab: 1) Push the button “Choose reference file” and upload dissolution test data from reference drug. 2) Push “Choose test file” and find the file with dissolution test data of the test drug. 3) Push the button “Choose report file” and select the name of the report file. After that there is only 4) “Start computations” and a coffe to make. The results will be displayed at the bottom of the window. Please bear in mind that the algorithm is very demanding in terms of CPU time, therefore observe progress bar at the bottom and be patient...
Linux users must instal libQt4Pas library for running this software