溶出数据处理PhEq_boostrap_Windows64V1.2资源-CSDN文库

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溶出数据处理PhEq_boostrap_Windows64 V1.2.zip （5个子文件）

PhEq_boostrap_Windows64

PhEq_bootstrap64.exe 3.96MB

ref_1.txt 962B

Documentation_PhEq_bootstrap1_2.pdf 362KB

test_1.txt 962B

PhEq_boostrap_src.zip 713KB

PhEq_bootstrap v 1.2

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.

Outline

1. Introduction......................................................................................................................2

2. How to start?....................................................................................................................2

3. Main GUI elements..........................................................................................................2

4. Theoretical background...................................................................................................6

5. Input and output files formats..........................................................................................6

6. Changelog........................................................................................................................9

7. Acknowledgments............................................................................................................9

8. Citation.............................................................................................................................9

9. License...........................................................................................................................10

page 1 of 24

1. Introduction

This program was developed as a help in establishing pharmaceutical equivalence by use

of FDA famous 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 values, 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?

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...

3. Main GUI elements

The GUI is built upon the TNotebook component from Lazarus LCL components palette.

It is divided into 3 sections: Main, Graph and About.

page 2 of 24

Fig.1. The “Main” page

page 3 of 24

Fig.2. The “Graph” page

page 4 of 24

Fig.3. The “About” page

page 5 of 24

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