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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.
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.
Create suitability tests
Learn how to create suitability tests in Dose-response analysis documents.

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.
    - 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.
      - Create assay elements
        Learn how to create assay elements in Dose-response analysis documents.
      - Create and assign preparation schemes
        Learn how to create preparation schemes and assign them to assay elements in Dose-response analysis documents.
      - Create and assign report groups
        Learn how to create report groups and assign them to assay elements in Dose-response analysis documents.
      - Select a regression model
        Learn how to select a regression model in Dose-response analysis documents.
      - Set up response data processing
        Learn how to set up response data processing in Dose-response analysis documents.
      - Set up data selection schemes
        Learn how to set up data selection schemes and assign them to assay elements in Dose-response analysis documents.
      - Create suitability tests
        Learn how to create suitability tests in Dose-response analysis documents.
      - Create reports
        Learn how to create reports for Dose-response analysis documents.
    - 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.

Create suitability tests

Learn how to create suitability tests in Dose-response analysis documents.

Before you begin

We recommend becoming familiar with the suitability tests concept of PLA 3.0 before beginning. For details, see the Suitability tests topic.

About this task

Created from scratch, Dose-response analysis documents do not contain suitability tests. In this example, we create one assay suitability test and three sample suitability tests.

Note: This task shows how to efficiently work with the document structure in this context. To see how you configure suitability tests in a practical example, see the Use case: Determine total human thyroxine (T4) topic.

Procedure

To create assay suitability tests:

In the Content editor of your Dose-response analysis document, go to Analysis > Suitability tests > Assay suitability tests.
In the Creatable elements pane, double-click F-test (hypothesis).
Result: Your assay document now has one assay suitability test for the lack of fit (default setting).

To create sample suitability tests:

Go to Analysis > Suitability tests > Sample suitability tests.
In the Creatable elements pane, double-click the following elements:
1. Test: Parameter/property point estimate
2. Test: Mean squares (ANOVA)
3. Test: Sum of squares (ANOVA)
Result: Your assay document now has three sample suitability tests.

For each of the suitability tests, configure the margins as required.

The following table shows possible margins for the tests used in this example:


Test type	Upper margin	Lower margin
Parameter/property point estimate	25	10
Mean squares (ANOVA)	64	/
Sum of squares (ANOVA)	256	/

Save the document.

Example

The following image from the 'Effective concentrations (ECx)' sample document shows a possible suitability test setup:

Figure 1. Suitability test setup in a Dose-response analysis document