Equivalence margin development

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

Examples

The examples are based on the Dose-Response Analysis Package sample document 'Equivalence margin development and verification'.

Equivalence margin development employing two test strategies

These images show overlay plots for development and simulation assays based on 16 tests. The tests are developed emplyoing two test strategies, Point estimate tests (strategy 1) and Equivalence and selected ANOVA term tests (strategy 2).

Margins have been developed for 24 Dose-response analysis documents, each containing a single curve. For comparison, the overlay plot of the development assays is shown in blue, followed by overlay plots of the simulation assays for strategy 1 and 2.

Equivalence test for parameter estimates

This plot shows the source assay values that were defined as relevant for the Equivalence 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).

The test, an excerpt of a document report, detects only one of the invalid assays.

Point estimate test for parameter estimates

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).

The test shown below detects only one of the invalid assays.