Regxpertpro f2 Select

Conventional f2 assessment is not just a calculation.

FDA and EMA/ ICH M9 apply different prerequisites for determining whether conventional f2 is applicable and which timepoints belong in the assessment for immediate - release drug products.

f2 Select applies both frameworks independently to the complete dissolution profile - screening eligibility, selecting the applicable timepoints, calculating f2 where appropriate and documenting how the conclusion was reached - so the outcome doesn't depend on who selected the timepoints.

Your dissolution Excel worksheet already does an important job.

It calculates f2 based on the timepoints entered manually into it. 

f2 Select addresses the decision before that calculation: which timepoints are eligible under the applicable regulatory prerequisites? 

Paste the five-column profile directly from your own worksheet, or use the RegXpertPRO f2 Select template if you need the required format:

Time-point | Reference mean % | Reference % RSD | Test mean % | Test % RSD

Most scientists can calculate f2.

The challenge is BEFORE the calculation:

• Is conventional f2 applicable?
• Which timepoints satisfy the FDA prerequisites?
• Which timepoints satisfy the EMA/ICH M9 prerequisites?
• Which timepoints should be excluded?

Your Excel sheet calculates f2 based on the timepoints entered into it.

f2 Select determines which timepoints are eligible for the f2 assessment under FDA and EMA/ ICH M9 prerequisites - then calculates and documents the result.

FDA and EMA/ ICH M9 apply slightly different prerequisites for conventional f2 calculation. That changes which timepoints are selected for the calculation. That's why dissolution profiles that look similar under one regulatory approach may not even qualify for comparison under another. Miss one prerequisite and your timepoints and similarity conclusion - shift.

And when that happens, the consequence is rarely just 'calculation error'. It can come back later as: wrong batch selection, a delayed bioequivalence decision or a regulatory deficiency asking you to recalculate the similarity factor with correct timepoints.

Even experienced scientists get this wrong. Not because they don't know the guidelines. But, because manually checking every prerequisite on every dataset, every single time often leaves room for misinterpretation.

That's exactly the challenge f2 Select is built to address - it assesses the complete dissolution profiles independently against both FDA and EMA/ ICH M9 prerequisites for eligibility and timepoint selection and calculates the f2 accordingly.

For each regulatory pathway, the assessment shows:

• whether conventional f2 is applicable
• the timepoints selected for f2 assessment
• calculated and reported f2, where applicable
• the similarity conclusion
• why calculation is blocked when prerequisites are not met
• the reasoning behind timepoint selection and the outcome
• a downloadable f2 assessment record

This makes the decision trail visible - so reviewers can see how the selected timepoints and conclusion were reached.

1. Paste the complete profile data

Copy the 5-column dissolution profile directly from Excel. Do not pre-select timepoints.
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2. Review the captured data

Confirm that the complete Reference and Test profile has been captured correctly.
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3. Run the assessment

f2 Select independently applies the FDA and EMA/ ICH M9 prerequisites to select applicable timepoints.
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4. Review and save the outcome
Review the selected timepoints, f2 result or blocking reason, conclusion and timepoint selection reasoning - for each regulatory pathway.

Download or print the assessment record for your files.

f2 Select applies the prerequisite frameworks described in the following regulatory guidance:

FDA: Dissolution Testing of Immediate release Solid Oral Dosage Forms

ICH M9: Biopharmaceutics Classification System - Based Biowaivers

The regulatory source documents remain the governing references. f2 Select operationalises recurring assessment criteria to support consistent application

Your first complete f2 Select assessment is free.

It includes:

• FDA pathway assessment
• EMA/ ICH M9 pathway assessment
• eligibility screening
• automatic selection of applicable timepoints
• calculated and reported f2 where applicable
• similarity conclusion
• f2 calculation blocking reason where applicable
• reasoning behind the assessment
• downloadable f2 assessment record

Purchase another assessment directly within f2 Select using RazorPay (India) or PayPal (International)

Working across multiple datasets or products?

3- and 6-month project/ team access is available. 

For project or team access: support@regxpertpro.com

f2 Select requires five columns:

Time-point | Reference mean % | Reference % RSD | Test mean % | Test % RSD

Use either your own worksheet or the RegXpertPRo Excel template. 

Points to remember:

• Enter all non-zero dissolution timepoints
• Do not pre - select timepoints
• Do not include the 0 - minute timepoint
• Maximum 10 timepoint rows
• Use non - confidential or anonymised product and batch identifiers

Then, copy the completed five-column dataset and paste it directly into f2 Select

RegXpertPRO f₂ Select web-based assessment tool is intended to support structured interpretation of immediate -release dissolution profile comparison data. 

It is not a validated GxP system and does not provide regulatory approval or quality release decisions. 

Final conclusions remain the responsibility of the user and their organisation.