The development of equivalence margins for use according to the US Pharmacopeia is a challenging task. PLA 3.0 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>.

Similarity Testing

Similarity testing is the key to success in highly precise biological assays. PLA 3.0 focusses on the challenge of margin development with an automated method, that turns the development of candidate equivalence margins into an easy task.

Example of an Equivalence margin development report in PLA 3.0