Module 9 2024

03/09/2024

Assay design & stats analysis

Statistical methods used for analysis of assays are typically based on the assumptions that responses are: • Normally distributed - Data can be log transformed to attain normality - USP 1033 “ Relative potency measurements are typically log normally distributed” • Homogenous

- Bias in the assay can be detected to certain extent • Independent

- More often than not – assay dilutions are pseudoreplicates rather than independent, so prepared from a common initial pre-dilution.

The Organisation for Professionals in Regulatory Affairs

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