Statistical Methods for Combined Accuracy and Precision Approaches for Validation

In this talk, we will review some of the advances provided for Analytical Procedure Validation, in documents such as ICH Q2(R2), Q14 and USP 1220.
We will explore what tools are available to derive the new Q2(R2) performance characteristic combining accuracy and precision, implemented under the form of Total Analytical Error (TAE).
The lecture will develop on how TAE perfectly answers the question of assay performance, and how it links to the Analytical Target Profile (ATP) and the Quality Target Product Profile (QTPP) more easily than traditional performance metrics (e.g. separated accuracy and precision), to ensure the assay results are fit-for-purpose.
Practical examples of implementation will be provided, including replication strategy and early routine control set up, based on TAE.