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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.
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.

Get started
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.
    - 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.
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.

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.

About response data processing

Response data processing defines how PLA 3.0 adjusts raw response values before using them for analysis. This step helps you prepare the data in a way that reflects the characteristics of your assay and improves comparability across samples and experiments.

Common processing operations include subtracting background signals, such as the absorbance of blank wells, or normalizing data, for example by dividing response values by the mean absorbance of maximum binding wells.

Dose-response analysis documents support the following response data processing methods:

Adjustment: A fixed value or the mean response of a specific assay element is subtracted from every response value. You can apply adjustments to a group of assay elements (for example, Standard or Test), an individual assay element, or a specific plate.
Normalization: The response value is divided by a fixed value or the mean response of a specific assay element. You can apply normalizations to a group of assay elements (for example, Standard or Test), an individual assay element, or a specific plate.
Transformation: The response value is transformed according to the function you select. You can employ logarithmic, square, and square root transformation functions.
Replicate averaging: The regression uses the average response of each dose step rather than the response values of individual replicates. As this method influences the degrees of freedom and the control limits, we recommend using it with care, for example, when using pseudoreplicates instead of true replicates.

Work with response data processing

For details on how to create and work with response data processing, see the Set up response data processing topic.