| https://link.springer.com/article/10.1208/s12248-023-00834-1 |
Comparison of two analytical procedures is the primary objective of a method transfer or when replacing an old procedure with a new one in a single lab. Guidance for comparing two analytical procedures is provided in USP <1010> based on separate tests for accuracy and precision. Determination of criteria is somewhat problematic for these comparisons because of the interdependence of accuracy and precision. In this paper, a total error approach is proposed that requires a single criterion based on an allowable out-of-specification (OOS) rate at the receiving lab. This approach overcomes the difficulty of allocating acceptance criteria between precision and bias. Computations can be performed with any simulation software. Numerical examples are provided for four experimental designs that are typical in a method transfer study. Finally, recommendations are provided to help the user set criteria that provide an acceptable probability of passing for practical sample sizes.
To view the full article through your AAPS membership:
Go to https://www.aaps.org/education-and-research/journals/the-aaps-journal. Click or tap if you trust this link." rel="noopener">https://www.aaps.org/education-and-research/journals/the-aaps-journal
Enter your AAPS credentials
Click "Member Access to Journals"
Click on the The AAPS Journal cover.
Copy and paste the url into the "Search" box, and click search
The full article should appear.
Follow The AAPS Journal via Twitter: https://twitter.com/theaapsjournal
and by Linkedin, https://www.linkedin.com/showcase/theaapsjournal/
------------------------------
Ho-Leung Fung Ph.D., FAAPS
Editor-in-Chief
University at Buffalo
Sarasota FL
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------