Step 1: Select Stage Testing Immediate Release
From the Dissolution ribbon, open Stage Testing and select Immediate Release.
Open Stage Testing from the Dissolution ribbon and choose Immediate Release.
Step 2: Complete the input table setup form
Complete all required fields in the setup form. Enter the number of time points, select the time unit, then click OK.
Complete the setup selections, then click OK.
Step 3: Enter the Stage Testing inputs and Calculate
Enter the Dataset Name and Description, when applicable. Enter the dissolution values and Q values only in the designated input cells highlighted in yellow for the current stage. Click Calculate.
Enter the current-stage inputs only in the designated yellow cells.
Step 4: Review the results
The results table will show PASS/FAIL status. The summary message below the results table indicates whether the current stage requirements were met or whether additional testing is required.
Step 5: Proceed to the next stage, if required
If the current stage requirements are not met, click Proceed to Stage 2 to continue testing with the required additional units. Enter the additional dissolution data and calculate the next stage. Repeat this process until the applicable stage requirements are met or Stage 3 testing is completed.
If required, proceed to the next stage and enter the additional dissolution data.