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Models
Five classes implement CalibrationModel. CLI --model keys are in backticks.
| Class | CLI key | Mean function | LOD | LOQ rule | Solver |
|---|---|---|---|---|---|
| PiecewiseCF |
piecewise_cf (default) |
yes | sliding window on a CV grid (<=) |
discrete knot search | |
| PiecewiseWLS | piecewise_wls |
yes | sliding window on a CV grid (<=) |
scipy TRF curve_fit
|
|
| EmpiricalCV | cv_empirical |
none | no (inf) |
sliding window on calibration levels (<=) |
group CV |
| OriginalWLS | original_wls |
yes | single grid point with CV strictly < threshold |
scipy TRF least_squares
|
|
| OriginalCV | original_cv |
none | no (inf) |
lowest level with CV <= threshold |
group CV |
I use PiecewiseCF for new curves. I use OriginalWLS or OriginalCV when I need the published script's rule, including its LOQ definition. EmpiricalCV is the model-free check. PiecewiseWLS is the TRF sibling of CF, kept so the two solvers can be compared on the same data.
Important
"Three consecutive passing points" is not the same object in every class. Piecewise bootstrap and delta evaluate a linspace grid from LOD to
These numbers are not an agency LLOQ. ICH M10 / FDA bioanalytical text is about QC accuracy and precision at LLOQ, not this estimator.
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