CI are required for validation submission. Once you can compute them, there is no reason to not always report them, even if only for information. The intervals may be simple or complex formula depending on the model and variance structure (mixed effect models). There is good literature on the topic and a lot of software provides those intervals natively (chose a statistical software that does).

Join Dr. Pierre Lebrun (Cencora – PharmaLex) to learn more about Practical Examples and Regulatory Expectations for the Validation of Biotechnological Analytical Methods – Linearity Testing, Total Error Approach.

Watch the On-Demand presentation now: https://bio-qc.com/practical-examples-and-regulatory-expectations-for-the-validation-of-biotechnological-analytical-methods-linearity-testing-total-error-approach/  

Plus, don’t miss his expert insights during the panel discussion on Addressing Challenges in Analytical Validation: Understanding ICH Q2(R2) and Integration with ICH Q14.