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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.
Dose-response analysis
Use Dose-response analysis documents to perform curve comparisons and create calibration curves.
Concepts for efficient setup
Find details on the concepts that support you when setting up and working with Dose-response analysis documents.

Get started
Explore PLA 3.0, its key features and ongoing enhancements, and learn how to log in and register.
Key concepts
Learn how the key concepts of PLA 3.0 form the structural foundation for your daily work, supporting method development from initial design to routine production.
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 the 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.
    - Analytical methods
      The Dose-Response Analysis Package supports a range of analytical methods.
    - Concepts for efficient setup
      Find details on the concepts that support you when setting up and working with Dose-response analysis documents.
      - Assay elements
        Assay elements are the building blocks of your assay. They are the starting point for the setup of your analysis workflow, as they represent the individual samples you want to evaluate in your analysis.
      - Preparation schemes
        Preparation schemes correspond to industry-standard practices of dose preparation protocols. They let you efficiently assign dilution sequences and replicate settings to assay elements, ensuring consistency and reducing redundant input during setup.
      - Report groups
        Report groups support you in organizing your samples for unified reporting and result interpretation. You can combine related samples in spike-and-recovery analysis and assay optimization or create summary statistics for interpolated values and dose-response curve characterization.
      - Regression model
        Regression models define how PLA 3.0 fits dose-response curves and calculates values from your assay data. Use them to set up regression analysis for your assay elements. Selecting the appropriate regression model is an important step in defining your assay.
      - Response data processing
        Use response data processing to configure the processing of response data, for example, to subtract the absorbance of blank wells or to divide response values by the mean absorbance of maximum binding wells.
      - Data selection schemes
        Data selection schemes define which data PLA 3.0 considers in the analysis. You can select, for example, which data points or dilution steps you want to include. The default scheme simply selects all data points.
      - Suitability tests
        Suitability tests let you prove the validity of your calculation. Use them to verify whether your dose-response analysis meets predefined criteria.
    - Work with Dose-response analysis documents
      Learn how to set up Dose-response analysis 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.
    - Use case: Determine total human thyroxine (T4)
      Thyroxine (T4) is a commonly measured thyroid hormone for diagnosis of the thyroid function. Determining the total quantity of human thyroxine in serum is a standard use case for interpolation on a calibration curve.
  - 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.
  - 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.
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.
Installation and update
Details on deployment, installation, and update of PLA 3.0, and its initial and advanced setup.
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.

Concepts for efficient setup

Find details on the concepts that support you when setting up and working with Dose-response analysis documents.

PLA 3.0 organizes documents to guide you through the setup from top to bottom. Each section in the document structure represents a key concept in the setup process, helping you configure your analysis efficiently and systematically.

The following figure maps the setup workflow to the document structure:

Two-panel diagram showing 'Assay setup' and 'Assay analysis' with numbered, color-coded steps. Assay setup includes assay layout, preparation schemes, and report groups (steps 1 to 3). Assay analysis includes data selection, regression model, response data processing, and suitability tests (steps 4 to 7).

To get started, begin with the first section, Assay elements, and work downward, configuring each setting based on your assay design and analysis goals.

Assay elements: Define the samples of your assay, that is, Standard, Tests, and Controls. For details, see the Assay elements topic.
Preparation schemes: Organize sample preparation with dilution steps, replicates, and concentrations (or dilutions). For details, see the Preparation schemes topic.
Report groups: Combine assay elements into groups for reporting and subgroup analysis. For details, see the Report groups topic.
Data selection schemes: Specify which data points or dilution steps are included in the analysis. For details, see the Data selection schemes topic.
Regression model: Select the analytical model for curve fitting, such as 4PL, 5PL, or 3PL. For details, see the Regression model topic.
Response data processing: Define how response data is adjusted, transformed, or normalized. For details, see the Response data processing topic.
Suitability tests: Establish criteria to prove the validity of your calculation results. For details, see the Suitability tests topic.