Equivalence margin development

The development of equivalence margins for use according to the US Pharmacopeia is a challenging task. PLA supports you with development assays which are used to develop the margins and verification assays that verify your test strategies. Test strategies are selections of available predefined or calculated margins that offer the possibility to include different strategies. The strategies can be visualized. The system is going to simulate a certain number of acceptable assays for every defined strategy to support the visual verification of the strategies. Besides this, the equivalence margin development offers a broad variety of equivalence tests.

At the end stands the development report that gives you many insights into the development process and results like for example detailed plots of the input assays.

The method supported by PLA 3.0 is a preferred method to calculate equivalence margins and is supported by the US Pharmacopeia <1032>.

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

Example

The following images from the 'Equivalence margin development and verification' sample document show overlay plots for development and simulation assays are based on 16 tests, developed with two different test strategies. Margins have been developed for 24 Dose-response analysis documents, each containing a single curve.

The following images from the 'Equivalence margin development and verification' sample document show the source assay values that were defined as relevant for the test. 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.