Module 9 2024

03/09/2024

Is the assay valid? • AAC passes… • Apply 2nd line of scrutiny – Sample Suitability Criteria Assay Design & Stats Analysis

pass

SSC each sample

AAC

• If samples pass criteria, each assay constitutes one result for that sample • Multiple assays per sample maybe required to produce a reportable result (routinely n=2 or n=3) • If one sample fails SSC, then that data is not used and the sample is repeated

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Assay Design & Stats Analysis

Robustness – advised to be performed as part of AP development (ICH Q14) • The robustness of an analytical procedure is a measure of its capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its • Method parameters assessed:

Incubation times

Different analysts

Different instruments e.g. more than one plate reader of the same model in the lab

Different lot numbers

• If the assay is not influenced by these different factors = robust assay.

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