There is general agreement that the development and regulatory approval process of advanced therapies can be accelerated by standardized measurement protocols for assays. Standard test methods will have the most benefit to the wider industry if they have broad application to many products. In many cases, there is no need for wider standardization of product-specific methods that can be locally optimized and validated. In the absence of standardized protocols, measurement assurance strategies and tools can be applied to any measurement process to assess the confidence in the assay result. The successful use of measurement assurance strategies to establish highly qualified assays maybe the first step to realizing “standardized assays.”
We define measurement assurance as knowing the level of confidence in the data needed to make a decision.
An Ishikawa (cause-and-effect) diagram is shown below that organizes potential sources of variability, which provides a graphical method to examine the factors that are major sources of variability and how they are related to one another. Applying a formal process for assessing sources of variability in an assay can help to reveal weakness in protocols.
NIST is actively developing methodologies to enable measurement assurance through experimental design and statistical analysis.
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