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Equivalence margin development with the Dose-Response Analysis Package

Dear Sir or Madame,

This is the second newsletter of our four-part newsletter series about our new add-on. The Dose-Response Analysis Package provides a range of additional biostatistical methods for immunoassays, ELISA, and more. It supports you in investigating equivalence for calibration curves and it provides enhanced data processing and analysis. New document reports and dashboards add to its value and usability. 

The package features several equivalence test and development options for calibration curves. You can employ equivalence and point estimate tests for parameter estimates and ANOVA terms. And you can use your historic assay runs to develop acceptance criteria. The package provides test strategy development, visualizations, and simulations.

Equivalence margin development

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>.

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

Read more and see an example.

Best regards
Mathias von Gellhorn
Marketing Manager

Stegmann Systems GmbH, Raiffeisenstr. 2, 63110 Rodgau, Germany
Phone: +49 (6106) 77010-0, Fax: +49 (6106) 77010-190
www.stegmannsystems.com


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