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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.
Analytical methods
The Dose-Response Analysis Package supports a range of analytical methods.
Spike-and-recovery analysis
Spike your Test samples with different concentrations of your analyte to identify matrix effects or determine the precision of your assay within the assay range.

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.
      - Interpolation on calibration curves
        Plot the observation data of the Standard sample and the Test samples, calculate the standard curve and determine the unknown concentration by interpolation on this curve.
      - Spike-and-recovery analysis
        Spike your Test samples with different concentrations of your analyte to identify matrix effects or determine the precision of your assay within the assay range.
      - Linearity-of-dilution assessment
        Determine the precision of your method at different levels of dilution.
      - Effective-concentration calculation
        Calculate the effective concentration (for example EC50) of your sample in the concentrations you require by adding additional calculations.
      - Curve comparisons
        Individually plot Test samples, and use the document dashboard or one of the document reports to compare the resulting curves. PLA 3.0 supports various analytical (regression) models.
    - 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.
    - 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.

Spike-and-recovery analysis

Spike your Test samples with different concentrations of your analyte to identify matrix effects or determine the precision of your assay within the assay range.

Figure 1. Interpolation plot for a group of spiked Test samples