topic method validation: % bias and recovery values from DoE? in Discussions

method validation: % bias and recovery values from DoE?

cbell9824 — Thu, 06 Mar 2025 18:48:43 GMT

In the qualification or validation of pharmaceutical/biotech analytical methods, we're obliged to report accuracy. ICHQ14 allows precision and accuracy to be studied together, making Custom DoE an ideal choice. But unless I'm missing it, it's not obvious that JMP reports accuracy (in terms of % bias or % recovery). Can anyone point me to which of the Analyze tools would give me those values from a DoE? Many thanks in advance!

Re: method validation: % bias and recovery values from DoE?

statman — Thu, 06 Mar 2025 20:01:16 GMT

Welcome to the community.

I will have to admit, I have worked with pharmaceutical companies in the past, but am not familiar with the use of the term accuracy as it relates to DOE. It is certainly part of measurement study.

https://www.jmp.com/support/help/en/19.0/?os=mac&source=application#page/jmp/linearity-and-bias-results-report.shtml

Accuracy is The difference between the observed average value of measurements and the accepted reference value (ISO 8402). Precision as it relates to measurement is the variation between successive measurements under stipulated conditions (Repeatability and Reproducibility).

Precision as it relates to DOE is impacted by the amount of noise in the experiment (st least that is how Box describes it)

Re: method validation: % bias and recovery values from DoE?

cbell9824 — Mon, 10 Mar 2025 12:46:03 GMT

Thank you Statman! The definitions you gave are understood and in line with those in ICH and USP guidance. We have a workaround that would let us calculate the average reference value and difference from observed (which we can obtain from the levels of reference concentration in a DoE). I was just surprised this isn't reported 'out of the box,' even recognizing JMP isn't pharma/biotech specific.

An ability to get accuracy parameters reported in JMP is all that stands in the way of being able to use JMP exclusively for generating and reporting method qualification and validation data.