How to Use the F1 / F2 Calculator
Step 1: Select F1 / F2 Calculator
From the Dissolution toolbar, click F1 / F2 Calculator.
Open the F1 / F2 Calculator from the Dissolution toolbar.
Step 2: Complete the input table setup form
Select the Number of Replicates, Number of Time Points, and Time Unit, then click OK. If a required selection is missing, complete the item identified in the validation message and click OK again.
Choose the setup values required for the comparison.
Step 3: Enter the dissolution data inputs
Enter Dataset Name and Description as applicable. Enter time points and dissolution values for Dataset A and Dataset B in the designated yellow input cells.
Enter time points and dissolution values for both datasets.
Step 4: Select filter options
Click Next. Review the calculated Mean and RSD values. You can either use the Auto-exclude feature as per FDA guidance, or manually select the time points to include.
Review Mean/RSD values and select the time points to include.
Step 5: Review Guidance Check
Review all Guidance Check items. Confirm at least three included time points, at least 12 replicates included in both data sets, matching dissolution time points, the 85% rule, and the applicable RSD limits for the selected time unit.
Review every Guidance Check item before calculating.
Step 6: Calculate F1 / F2
Click Calculate to compute f1 and f2. If a guidance criterion is not met, review the warning before choosing whether to continue with the calculation.
Calculate f1 and f2 after reviewing the guidance checks.
Step 7: Review results
The final results will be displayed. If any input changes afterward, click Recalculate before relying on the displayed results.
Review the f1/f2 values, acceptance criteria, and Pass/Fail results.
