For the estimation of the relative potency (RP) for each test sample in the assay, QuBAS analysis follows a series of steps based on the USP guidance <1034>: Analysis of biological assays USP <1034>.
Step 1:
Check system suitability criteria (also known as assay acceptance criteria)
Controls (if used)
Check summary statistics, e.g. mean value
Reference standard
Fit model to reference standard alone and check criteria, e.g.
Goodness of fit of the model
Parameter values
Variability of replicates around the fitted model
Quality Control (QC) (if used)
Fit model independently of the reference standard model and check criteria, e.g.
Goodness of fit of the model
Variability of replicates
Check parallel to reference standard
Fit parallel model to reference standard and QC sample and check acceptance criteria, e.g.
Relative potency of QC sample
Step 2:
For each test sample in turn
Check sample suitability criteria(also known as sample acceptance criteria)
Fit model independently of the reference standard model and check criteria, e.g.:
Goodness of fit of the model
Check parallel to reference standard
Fit parallel model to reference standard and test sample pair.
