How to Use Stage Testing for Extended Release Products
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 by selecting the appropriate values for your test, then click OK. If any required information is missing, follow the prompt to complete the applicable field before continuing.
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.
Enter dissolution data and the applicable Min/Max and NLT specifications.
Step 4: Calculate the current level
After completing the required dissolution and specification inputs, click Calculate. The Extended Release setup requires at least one Min/Max range and one NLT final-time minimum. If a validation message appears, correct the identified input and click Calculate again.
Calculate after all required dissolution and specification inputs are complete.
Step 5: Review the results
Review the results.
Review the Acceptance Criteria and PASS/FAIL status for the current level.
Step 6: 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.
