Module 9 2024

03/09/2024

Assay Design & Stats Analysis

Is the assay valid?

Assay Acceptance Criteria (AAC)/ System Suitability Criteria (SSC) • Parameters of the assay used to determine if the Reference material is performing in expected manner e.g D/A = signal window, %CV of replicate measurements

D = asymptote

y = D + A – D

1 + (x/C) B

B = Hill Slope

C = inflection point

response (y)

A asymptote

concentration (x)

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Assay Design & Stats Analysis

Is the assay valid?

Assay Acceptance Criteria (AAC)/ Sample Suitability Criteria (SSC) • Parameters of the assay used to determine if the Reference/Sample material is performing in expected manner • Reference criteria (AAC) = linearity (e.g. R 2 of curve fit), max number of outlier points, size of signal response (e.g. > 1.5-fold signal over baseline), %CV between replicates of serial dilutions. • Sample criteria (SSC) = A and D parameter ratios, Reference Parm A/Sample Parm A 0.7-1.3, number of outliers, % CV between replicates of serial diluitons.

The Organisation for Professionals in Regulatory Affairs

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