Module 9 2021

24/03/2021

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)

The Organisation for Professionals in Regulatory Affairs

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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

AAC

The Organisation for Professionals in Regulatory Affairs

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