Step 1: Select Stage Testing Extended Release
From the Dissolution ribbon, open Stage Testing and select Extended Release.
Open Stage Testing from the Dissolution ribbon and choose Extended 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
Enter the Dataset Name and Description. Enter the dissolution values and the specifications in the designated yellow input cells for the current level. Click Calculate.
Enter dissolution data and the applicable Min/Max and NLT specifications.
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.
Review the Acceptance Criteria and PASS/FAIL status for the current level.
Step 5: Proceed to the next level, if required
If the current level requirements are not met, click Proceed to Level 2 or Proceed to Level 3, as applicable, to continue testing with the required additional units. Enter the additional dissolution data for the new units and calculate the next level. Repeat this process until the applicable Extended Release requirements are met or Level 3 testing is completed.
