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Data analysis
Data analysis add-ons offer a wide range of capabilities, ranging from analytical methods over comprehensive analysis to statistical process control. PLA 3.0 also provides a set of add-ons that support and supplement data analysis add-ons.
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.
Dichotomous assays
Use Dichotomous assay documents to calculate relative potencies of Test samples based on binary input values, such as the fraction of specimen that exhibits one of two possible responses. If you provide information on the stock solutions or raw materials, you can also determine absolute potencies based on several types of calculations.

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 statistical process control. PLA 3.0 also provides a set of add-ons that support and supplement data analysis add-ons.
- 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.
- Biological Assays Simulation Package
  Use the Biological Assays Simulation Package to create simulations of quantitative response assays (QRAs) and use the Quantitative response assay document type of PLA 3.0 to store the simulated data.
- 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.
  - Installation
    Find details on the system requirements for the Dichotomous Assay Package add-on and the steps to install the add-on in your environment.
  - Dichotomous assays
    Use Dichotomous assay documents to calculate relative potencies of Test samples based on binary input values, such as the fraction of specimen that exhibits one of two possible responses. If you provide information on the stock solutions or raw materials, you can also determine absolute potencies based on several types of calculations.
    - Assay setup
      To support you in setting up your assay, Dichotomous assay documents provide a set of concepts you should be familiar with when working with this document type.
    - Suitability testing
      Assays are based on curve similarity. This provides the opportunity to check the validity of calculations every time they are performed. Use suitability tests to ensure valid results. A typical suitability test you can use is one that checks for similarity/parallelism.
    - Calculation
      Calculate an assay document once you have completely set it up. Results of the calculation are added to the assay document.
    - Literature
  - Use case: Determine insulin concentration in mouse convulsion
    Caused by high blood sugar level, leg cramps are a common side effect of diabetes. This effect can be countered by administering insulin, which lowers the blood sugar level. As a too high dose of insulin can also cause leg cramps, it is crucial to find the correct concentration.
  - Reference information
    The reference provides reference information on the document types of the Dichotomous Assay Package.
- 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.
- Generic Document Types Package
  Use the Generic Document Types Package add-on to document general information.
- Integration Report Package
  Use the Integration Report Package for creating reports in additional file formats that are not covered by the standard PLA 3.0 reporting functionality. These reports can be used for example for automated processing in third-party software.
- Measurement Documentation Package
  The Measurement Documentation Package add-on is a universal add-on for documenting different aspects of a measurement. Its documents can be referenced by other document types, for example, Quantitative response assays.
- 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).
- Split Assay Package
  Use the Split Assay Package to split a Quantitative response assay with several Test and Control samples into individual assays, each with the Standard and one Test or Control sample.
- Toolkit for Biological Assay Package
  Use the Toolkit for Biological Assay Package to modify the analytical settings of larger sets of Quantitative response assays or split Quantitative response assays with more than one test or control sample into individual assays.
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.

Dichotomous assays

Use Dichotomous assay documents to calculate relative potencies of Test samples based on binary input values, such as the fraction of specimen that exhibits one of two possible responses. If you provide information on the stock solutions or raw materials, you can also determine absolute potencies based on several types of calculations.

About this document type

Dichotomous assays (quantal response assays or binary assays) are biological dilution assays based on a binary outcome. They analyze data you collect in binary form: Of a total number of specimen (n), a measurable number of specimen (m) shows a specified response while the rest does not show this response. You provide both n and m for analysis.

Note: Dichotomous assays differ from Quantitative response assays in that the dichotomous response is measured as all or none (responded versus did not respond), while the quantitative response is measured on a continuous scale provided, for example, by light absorbance or fluorescence.

Dichotomous assays require at least one Standard sample (reference) and one Test or Control sample to calculate potency. They usually involve a range of assay elements with data measured at different dilutions (or concentrations) of the active ingredient. You can use the logit or probit method to calculate relative potencies.

Tip: You can identify assays of this document type by the

icon in the upper right corner of the Content editor.

Document structure

Each Dichotomous assay document has three default sections, that is, Documentation, Setup, and Analysis, plus an optional Settings and one or more Comment sections.

Figure 1. Sections of a Dichotomous assay document displayed in the Content editor


Section	Description
Documentation	Lets you provide information on operators, analyte, reagents, and equipment.
Setup	Contains all properties related to observation data and measurement such as dilution steps and response values.
Analysis	Defines how assays perform the statistical analysis.
Settings	Define how you want to graphically display assay results.
Comment	Add extra information to your assay. The PDF reports display the comments you add on the first page.