It's possible to compute the intermediate precision (IP) or total analytical error (TAE) for a reportable value computed from replicates. Hence, if one got an ATP with minimal requirements on IP or TAE on reportable value, it's easy to compute the IP and TAE under the format (something like Sip(MxN) = Sb/M + Sw/(M*N), with M number of runs and N number of replicates).

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.