Dose-Response Analysis Package

Current add-on version: 1.0.0 (build 16)

The Dose-Response Analysis Package provides various biostatistical methods for immunoassays, ELISA, and more. It supports you in investigating equivalence for calibration curves, provides enhanced data processing, and options for subgroup analysis.

Note: The Dose-Response Analysis Package is not intended for relative potency calculations, as those are covered by the Biological Assay Package.

The Dose-Response Analysis Package supports a range of biostatistical methods, including:

Interpolation on calibration curves
Spike-and-recovery analysis
Linearity-of-dilution assessment
Effective-concentration calculation
Curve comparisons
Equivalence margin development

To illustrate how you can use the Dose-Response Analysis Package in connection with these methods, we provide sample documents you can download when activating the add-on in PLA 3.0.

Additional information about each sample document is provided in the document's Comment section.

Interpolation on calibration curves

Plot the observation data of the Standard sample and the Test samples, calculate the standard curve and determine the unknown concentration by interpolation on this curve.

The following image from the 'Linear calibration curve (enhanced response data processing)' sample document shows results for Test sample TST4, with response data being adjusted by a fixed value of '1.'

Figure 1. Interpolation plot for a group of Test samples

Spike-and-recovery analysis

Spike your Test samples with different concentrations of your analyte to identify matrix effects or determine the precision of your assay within the assay range.

Figure 2. Interpolation plot for a group of spiked Test samples

Linearity-of-dilution assessment

Determine the precision of your method at different levels of dilution.

The following image from the 'Linearity of dilution assessment' sample document shows results for an undiluted Test sample and three dilutions of the undiluted sample. Predilution factors are assigned to the diluted samples. The concentration is defined as the determined concentration of the undiluted sample.

Figure 3. Interpolation plot for Test samples assigned to the Medium-level sample report group

Effective-concentration calculation

Calculate the effective concentration (for example EC50) of your sample in the concentrations you require by adding additional calculations.

Figure 4. EC50 calculation for a test sample

Curve comparisons

Individually plot Test samples, and use the document dashboard or one of the document reports to compare the resulting curves. PLA 3.0 supports various analytical (regression) models.

The following image shows regression plots for three multi-dose samples.

Figure 5. Regression plot for a group of multi-dose samples

Equivalence margin development

Use your historic assay runs to develop acceptance criteria. The Dose-Response Analysis Package provides test strategy development, visualizations, and simulations.

This plot shows the source assay values that were defined as relevant for the Point estimate test for parameter estimates. The horizontal lines represent the margins developed for this test. Development assays are indicated in blue. Verification assays are indicated in green (valid assays) and red (invalid assays).

Figure 6. Point estimate test for parameter estimates