Module 9 2024

03/09/2024

Assay Design & Stats Analysis

We want relative potency results to be precise and accurate: • Precision – closeness of agreement between a series of measurements • Accuracy – closeness of agreement between the measured value and Reference.

inaccurate imprecise

inaccurate precise

accurate precise

accurate imprecise

The Organisation for Professionals in Regulatory Affairs

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Assay Design & Stats Analysis

Precision increased by: • Controlling or reducing factors causing variability e.g cell number, temperature. • Increasing replicates within an assay (e.g. n=2 or n=3) and number of assays which produce a reportable result • It’s not possible to control all variables – try to identify the most influential. • Also, practically there are limitations on the number of replicates and assays to be run.

The Organisation for Professionals in Regulatory Affairs

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