USP-NF Stimuli Article on Analytical Method Precision Comparisons

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5-7 December 2023

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In the Pharmacopeial Forum, PF 48(5), a stimuli article entitled "Analytical Method Precision Comparisons—A Special Case" was published. The text written by Keith M. Bower is available on PF Online. The deadline for submitting comments is November 30, 2022.

The article discusses a particular case relating to the collection of specific types of data in the biopharmaceutical industry. The example described is based on the following assumptions:

• "A procedure is to be transferred from an "old" laboratory to a "new" laboratory, with no practically relevant changes in the execution of the procedure across the two laboratories.
• A reference standard (or standards, if there has been requalification during the product life cycle) has been repeatedly tested in the "old" laboratory.
• Method precision will be assessed by comparing precision at the "new" laboratory with the precision at the "old" laboratory."

The stimuli article outlines a Microsoft Excel formula to assist in correctly concluding precision comparability.

The author concludes that "using point estimates in a procedure transfer addressing precision can lead to incorrect conclusions, even when large data sets may be available for statistical analysis."