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>.

The Dose-Response Analysis Package makes equivalence testing and equivalence margin development available for all kinds of dose-response analysis.

Features Equivalence Margin Development

  • Candidate calculation for up to 27 different equivalence margins
  • Automatic aggregation of data from historic development assays
  • Strategy verification with verification assays
  • Comparison and visualization of different testing strategies
  • Simulation of developed test system