At first sight, many aspects of developing analytics for biologically relevant molecules seem simplistic. You need a target – of course! But then, interesting interrogations intrude – How do we know what we are measuring? How do we know what we are not measuring? How do we know today is the same as yesterday is the same as tomorrow? This list is long, and the FDA will ask you every question (despite the lack of a formal guidance) to ensure “safe and effective for its intended use.” Fortunately, they have also graciously given you the answer – intended use, a.k.a., the Context of Use (COU). The COU, a complete and precise statement that describes the appropriate use of the biomarker, is the key. Starting with the COU and working backwards, you may begin the process of designing measurement performance characteristics of the desired target assay under development and determine the range of conditions under which the biomarker will give reproducible and accurate data to support its clinical utilization. Examples, both real world and theoretical, will be utilized to demonstrate how this process may be applied as a useful drug development tool.
Acquire the understanding of why the COU is important not only for the qualification, but the assay validation as well
Employ the COU to construct the relevant requirements necessary to correctly validate an analytical method to support that specific COU
Explain how the COU and Clinical Utility drive parameters behind Analytical Validation