Dissolution profile comparision-Pharmaceutical industry

[#1]

Hi to everyone.

I am a beginner using JMP and I am tryinig to compare two dissolution test using F2 Analysis but I do not how to do it. Could you please share an example of table used to compare two dissolution profiles using F2 Analysis? If you also can add some screenshots of the procedure since the beginning I would thank you so much.

I use JMP 17.0.0

Thanks for your support.

Srochera.

[#2]

Hi @srochera,

Welcome in the Community !

Have you checked the JMP Help section related to Fit Curve platform ?

There is an example of dissolution curve analysis using F2 similarity factor : Additional Example of the Fit Curve Platform

You can find the dataset used for this example in menu Help, Sample Index, Nonlinear Modeling, Dissolution DOE or run this JSL script:

Open("$SAMPLE_DATA/Dissolution DoE.jmp")

If you would like a more personalized answer, can you provide more details on your context : factors used, project context, target, reference batch, anonimized dataset, ... ?

I hope this first answer will help you.

[#3 · Accepted solution]

Hi @srochera 

Here is a Step-by-Step guide for F2 Dissolution Analysis in JMP
Step 1: Open JMP and Load the Data Table
Open JMP software.
Load your data table into JMP. Ensure your data is in the tall format with columns for Set, Batch, Tablet, Time (mins), and % Disso. If the data is not in the tall format, rearrange it using the Table menu functions in JMP.

Step 2: Navigate to Fit Curve
In the JMP main menu, go to Analyze.
Select Specialized Modeling.
Click on Fit Curve.

Step 3: Configure the Fit Curve Dialog Box
In the Fit Curve dialog box, choose Rows as Functions as seen in the screenshot below.
Select the columns for analysis:
Y, Response: Choose % Disso (60 mins), % Disso (120 mins), % Disso (240 mins), and % Disso (360 mins).
Group: Choose Batch.
Click OK to proceed.

Step 4: Perform the Analysis
In the Fit Curve window, click on the red triangle menu next to Fit Curve to open the options. 

Navigate to Dissolution curve Analysis.

Select  Model-free comparisons F2 Analysis from the menu. This option performs a dissolution curve analysis using the F2 similarity factor, which measures the similarity of percent dissolution between the curves of the reference tablet and the curves of the test tablet.

The Dissolution Curve Specification dialog box allows you to configure important parameters for the F2 analysis, including the reference batch, significance level, number of bootstrap samples, and random seed.

Step 5: Interpret the Results
JMP will generate the fitted curves and statistical outputs for the dissolution data.
Review the results to analyze the dissolution profiles for different batches and compare the innovator and comparator data.

The F2 Analysis Summary in JMP provides critical information for interpreting the dissolution profile comparison between different formulations and the reference batch. This summary includes several key elements: the Group column lists each formulation being compared to the reference batch, while the F2 column displays the F2 similarity factor calculated for each formulation. The Lower 90% BCa Limit and Upper 90% BCa Limit columns provide the lower and upper bounds, respectively, of the 90% bias-corrected and accelerated bootstrap confidence interval for each formulation's F2 value. Finally, the Conclusion column indicates whether the formulation is similar or not similar to the reference based on the calculated F2 value, with similarity suggesting comparable dissolution profiles between the tested formulation and the reference.

Find the sample dataset attached. The JMP dissolution Curve Fit platform performs both model-dependent and model-independent analyses. JMP F2 fits the BCa F2 (bias-corrected and accelerated F2).

For background information on BCa F2 and model-dependent and model-independent dissolution, refer to these blogs.

The Statistical Basis of BCa Bootstrap f2 Dissolution

Exploring Model-Dependent and Model-Independent Approaches to Dissolution Modeling

To learn more about the regulatory aspects of dissolution testing and the methods prescribed by major regulators, go here:  Understanding Regulatory Dissolution Testing

For a comprehensive global regulatory overview of dissolution testing for similarity factor f2 go here: Similarity Factor f2: A Global Overview

[#4]

Dear Chandramouli_R,

Thank you very much for your answer, I really appreciate it and I think it will help me a lot.

Regards.

[#5]

Hi @srochera : Different agencies have different guidance for how f2 can and can't be used, so you will want to familiarise yourself with the following.

https://www.fda.gov/media/70936/download

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4706290/

https://medcraveonline.com/BBIJ/BBIJ-07-00237.pdf