The Equivalence Margins Development Visualization Tool

Dear Sir or Madam,

Today we take a closer look at the visualization tool of the Equivalence Margin Development document. The visualization tool is available in the Biological Assay Package (25 or higher). It's also available in the Dose Response Analysis package.

What does the visualization tool offers you?

For any set of test system, whether developed from historical assays by the Equivalence Margin Development or entered manually, the visualization tool generates new Standard/Samples pairs that would pass the test system.

Why should you use the tool?

Visualization can be used for comparing different test strategies to clarify which of your tests are particularly relevant for determining sample suitability, which test are superfluous, or whether we still need additional tests to ensure that the test system is powerful enough to detect anomalous results.

If you developed your test system using historical data, we already know that most of our typical assays will pass the test system developed by the Equivalence Margins Development. The visualization tool will help you to understand which unusual curves would still pass the test system. Since curves are generated randomly, the visualization tool will often find curves that look rather different from our development assays, but that would still pass your test system.

How to configure the visualization tool?

The visualization tool creates plots that contain a pair of curves, one curve for the standard and the sample each. Using the Max Configurations element, we can control how many pairs of curves are generated. Usually, 30 pairs of curves are sufficient to get an impression what curve shapes will pass the test systems.

Depending on the test system, it can be difficult (or even impossible) to find acceptable curve pairs. Using the Max Simulations element, you can control how many pairs of candidate curves are generated. If Max Simulations is reached before Max Configurations are found, only the configurations found up until that point are included in the report. Depending on the choice of Max Configurations, Max Simulations and the specific test system, creating the visualization may take a few moments.

For visualizing a test system that includes equivalence tests, you can also configure the standard errors and the covariances at the element Simulation Space. If not explicitly configured, these will be estimated from the development assays. There are also settings to configure the Model, the Logarithm Base, the Degrees of Freedom, the Transformed Dose Range and the Response Range. However, these elements are only taken into account when no development assays are referenced.

If you have any questions regarding this topic, please do not hesitate to contact for all other questions.

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