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Data analysis
Data analysis add-ons offer a wide range of capabilities, ranging from analytical methods over comprehensive analysis to assay workflows and statistical process control.
Dose-Response Analysis Package
The Dose-Response Analysis Package provides various biostatistical methods for immunoassays, ELISA, and more. It supports you in investigating equivalence for calibration curves, provides enhanced data processing, and options for subgroup analysis.
Equivalence margin development
Use Equivalence margin development documents to develop and verify test systems based on historic assays and apply these test systems in current runs of dose response assays.
Work with Equivalence margin development documents
Learn how to set up Equivalence margin development documents step by step. The tasks guide you through each part of the document setup and show you how to efficiently work with core concepts.
Select equivalence margins
Learn how to select equivalence margins in Equivalence margin development documents to define the acceptance criteria for passing and failing assays.

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Explore PLA 3.0, its key features and ongoing enhancements, and learn how to log in and register.
User interface
PLA 3.0 supports you in your daily work by providing a set of graphical and textual user interface elements. Learn about the different elements and how to use them efficiently.
Key concepts
Details on documents and templates, the data editors and the Content editor of PLA 3.0. Learn about the position factors and data aggregation features.
Data analysis
Data analysis add-ons offer a wide range of capabilities, ranging from analytical methods over comprehensive analysis to assay workflows and statistical process control.
- Biological Assay Package
  Use the Biological Assay Package for potency analysis of biological assays. The add-on comes equipped with a highly flexible test system to qualify your assay. You can perform combination calculations to obtain a reportable value from independent assay runs and use historic assay data to develop equivalence margins.
- bioMérieux Endotoxin Detection Assay Package
  Use the bioMérieux Endotoxin Detection Assay Package add-on to perform endotoxin testing based on recombinant factor C (rFC), a synthetic alternative to naturally sourced reagents derived from horseshoe crabs, as offered by the bioMérieux company.
- Control Chart Package
  The Control Chart Package allows sophisticated statistical process control (for example, by plotting Shewhart I-Charts as recommended in the USP <1010>). It provides visualization options for intervals, subcharts and sidecharts, and allows you to define colors by a secondary characteristic. You can also define rules based on events and time frames.
- Dichotomous Assay Package
  Use the Dichotomous Assay Package to analyze biological assays based on quantal (binary) responses by fitting probit or logit models to estimate the potency of your samples.
- Dose-Response Analysis Package
  The Dose-Response Analysis Package provides various biostatistical methods for immunoassays, ELISA, and more. It supports you in investigating equivalence for calibration curves, provides enhanced data processing, and options for subgroup analysis.
  - Installation
    Find details on the system requirements for the Dose-Response Analysis Package add-on and the steps to install the add-on in your environment.
  - Dose-response analysis
    Use Dose-response analysis documents to perform curve comparisons and create calibration curves.
  - Equivalence margin development
    Use Equivalence margin development documents to develop and verify test systems based on historic assays and apply these test systems in current runs of dose response assays.
    - Concepts for efficient setup
      Find details on the concepts that support you when setting up and working with Equivalence margin development documents.
    - Work with Equivalence margin development documents
      Learn how to set up Equivalence margin development documents step by step. The tasks guide you through each part of the document setup and show you how to efficiently work with core concepts.
      - Select and set up source assays
        Learn how to select and set up source assays for Equivalence margin development documents.
      - Select equivalence margins
        Learn how to select equivalence margins in Equivalence margin development documents to define the acceptance criteria for passing and failing assays.
      - Define test strategies
        Learn how to define test strategies in Equivalence margin development documents.
      - Set up visualization
        Learn how to set up visualization options in Equivalence margin development documents.
      - Export and reuse test strategies
        Learn how to export the test strategies of an Equivalence margin development document as a Test system definition document.
  - Test system definition
    Use Test system definition documents to define a collection of suitability tests and corresponding margins for dose response assays.
  - Reference information
    Find reference information on the document types of the Dose-Response Analysis Package add-on.
- Microbial Assays for Antibiotics Package
  The Microbial Assays for Antibiotics Package for PLA 3.0 is your software for assessing the potency of antibiotics. This add-on supports various methods, that is, cylinder-plate, turbidimetric, and combination of microbial assays. It enables you to closely follow the guidelines laid out in the United States Pharmacopeia (USP <81>) and the Japanese Pharmacopoeia (JP 4.02).
- Supporting add-ons
  Find details on add-ons that support and supplement data analysis add-ons.
Data import
Use data acquisition and data import add-ons to import external response values and observation data into PLA 3.0 for further processing and evaluation.
Installation
Details on the deployment, installation, initial and advanced setup of PLA 3.0.
Licensing
Details on the licensing solution of PLA 3.0, the available licensing options, and the activation and management of licenses.
Administration
Details on system administration tasks such as setup and maintenance of databases and add-ons, user accounts, access rights, and migration and update procedures.
Regulatory compliance
PLA 3.0 supports you in achieving compliance with regulations such as ISPE GAMP^® 5 and 21 CFR Part 11. It also provides options to validate PLA 3.0 in your environment.
PDF downloads
Download PDF guides of current and previous framework and add-on versions.
Sample lab
Meet the team at Stegmann Labs, where PLA 3.0 plays an essential role in every step of bioassay management.
Glossary
Find definitions of terms.

Select equivalence margins

Learn how to select equivalence margins in Equivalence margin development documents to define the acceptance criteria for passing and failing assays.

Before you begin

We recommend becoming familiar with the margin development concept of PLA 3.0 before beginning. For details, see the Margin development topic.

Procedure

In the Content editor of your Equivalence margin development document, go to Margin development.
By default, PLA 3.0 offers a variety of property point estimate tests, equivalence tests for single parameters, and tests on ANOVA terms. Remove the tests you do not want to use and set up the remaining according to your requirements.

Important: Removing a test from margin development also removes this test from the test strategy and visualization configuration.
Save the document.

Example

The following image from the 'Equivalence margin development and verification' sample document shows a possible setup with 15 tests:

Figure 1. Sample setup of tests for equivalence margin development