PLA 3.0 Dose-Response Analysis Package - Comprehensive Analysis

Dear Sir or Madam,

with our new PLA 3.0 Dose-Response Analysis Package* you can perform dose interpolation/extrapolation of concentrations, analyze the curves, and visualize your results in a report.

The Package provides features to support your comprehensive analysis:

  • Control Charts are required for the perfect control of your assay. In PLA 3.0 the data is directly aggregated into the chart allowing you to set up control charting in complete compliance with the requirements of regulated environments. Read more below …
  • 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. Read more below …

Control Charts - Monitoring, Statistical Process Control

The Control Chart document type in PLA 3.0 allows the monitoring of different parameters of your bioassay. Define any number of monitoring parameters and different limits to keep your assay under control. The data flows from the individual runs into the control charts automatically.

The Control Chart document can be used in two ways:

  • You can edit or import data from any source, allowing you to use the monitor chart universally.
  • Or you can directly aggregate the corresponding data from your calculation results as required in regulated environments.

Compliant Data Aggregation
With the control chart document you can monitor your biological assays in a compliant manner. No manual input in spreadsheets or other programs is required.

Limit Definitions
Set up any number of limits for your control chart and assign severities to the limits (e.g. warning limits, error limits). You will receive a report stating the limit violations. In addition to this any limit can be assigned to a date range, allowing your limits to vary e.g. when your assay system changes.

Equivalence Margin Development - for similarity testing

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.

*Important, please note: The current version of the package is a technology preview. It has not been released yet and has not been finally qualified for use in a productive system. The final package will be available for PLA 3.0.5 or higher and will be free of charge for all customers with an active support contract.

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