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Obtaining acceptance criteria limits for potency assay

Hi,

We are trying to set acceptance criteria limits for a potency assay. Most of the data are EC50, relative potency values and ratios. We have so far used the control charts with the moving range (MR) as limits or with levey jennings (LJ). However, the LJ limits which JMP calculates are often too wide and the MR ranges often seem unsuitable (limits widening after removal of an outlier).

I am new to JMP so am still learning about the software, are there other charts/graphs which can help setting these limits? Or recommend LJ/MR for this type of data limit setting?

Thanks!

Analytics

Data Table

Re: Obtaining acceptance criteria limits for potency assay

JMP can perform many calculations and analyses. What is the accepted method used in your field to determine such criteria?

Re: Obtaining acceptance criteria limits for potency assay

Normally we work with PK and Biomarker assays and so use confidence intervals or standard PK acceptance criteria - 80-120% theoretical. However for this study we want to set limits based around the data we have generated.

Re: Obtaining acceptance criteria limits for potency assay

You could explore tolerance intervals as a way to set specification/acceptance limits.

JMP help: tolerance intervals

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