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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.
Reference information
Find reference information on the document types of the Dose-Response Analysis Package add-on.
Document elements
Find reference information on the document elements in the document types of the Dose-Response Analysis Package add-on.
A–D
Find reference information on document elements of the Dose-Response Analysis Package, letters A to D.
Column: Verification assay

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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.
  - 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.
    - Dose-response analysis documents
      Find details on the document structure of Dose-response analysis documents and access reference information on particular document elements.
    - Equivalence margin development documents
      Find details on the document structure of Equivalence margin development documents and access reference information on particular document elements.
    - Test system definition documents
      Find details on the document structure of Test system definition documents and access reference information on particular document elements.
    - Document elements
      Find reference information on the document elements in the document types of the Dose-Response Analysis Package add-on.
      - A–D
        Find reference information on document elements of the Dose-Response Analysis Package, letters A to D.
        A upper asymptote (nonlinear models)
        A-D difference of asymptotes (nonlinear models)
        A/D ratio of asymptotes (nonlinear models)
        Activated
        Additional calculations
        Adjustment
        All sequence steps
        Allow subfolder
        Allow subfolders
        Alpha
        Amount
        Amount of the source material
        Analysis
        Analysis purpose
        Analyte quantity per amount unit
        Analytical model
        Assay element
        Assay element
        Assay element scope
        Assay element scope
        Assay element type scope
        Assay element type scope
        Assay elements
        Assay suitability tests
        Author
        B parameter (nonlinear models)
        Base
        C parameter (nonlinear models)
        Column key
        Column key
        Column key
        Column key
        Column: Assay element
        Column: Boolean
        Column: Date
        Column: Date/time
        Column: Development assay
        Column: Document reference
        Column: Document reference
        Column: Exclude assay
        Column: Floating-point number
        Column: Integer
        Column: Memo (multiline text)
        Column: Observation group
        Column: Position factor
        Column: Response value
        Column: Scientifically acceptable
        Column: Section
        Column: Sequence step
        Column: Technical-outlier flag
        Column: Text
        Column: Time
        Column: Verification assay
        Column: Well ID
        Comment
        Concentration: Defined by source material
        Concentration: Defined by stock solution
        Confidence level
        Confidence level (%)
        Config
        Config
        Control
        Covariance of A upper asymptote and D lower asymptote
        Creation time
        D lower asymptote (nonlinear models)
        Data selection scheme
        Data selection scheme
        Data selection schemes
        Data source
        Data table
        Date
        Date
        Deactivated
        Degrees of freedom
        Delta
        Dilution factor
        Direction
        Display color
        Display horizontal lines
        Display vertical lines
        Dixon test
        Document mode
        Document property filter
        Document property import
        Document type
        Documentation
        Dose-response analysis
        by Assay element
        by Assay element
        by Fixed value
        by Fixed value
      - E–L
        Find reference information on document elements of the Dose-Response Analysis Package, letters E to L.
      - M–R
        Find reference information on document elements of the Dose-Response Analysis Package, letters M to R.
      - S–Z
        Find reference information on document elements of the Dose-Response Analysis Package, letters S to Z.
    - Digest of document properties for data aggregation
      Find a list of property keys available for data aggregation in 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.

Column: Verification assay

Marks dataset rows as verification assays. Rows marked as verification assays (value set to 'true') are used to test derived margins.

Important: To use a row as verification assay, also set the value of the Development assay column to 'false'.

Tip: Use the Scientifically acceptable column to indicate whether you expect the verification assay will be accepted or rejected.


Data type	Multiplicity	Usage	Default value
Node	1...1	required	none

/Equivalence margin development (Dose-response analysis)/Data table/

Column: Verification assay

This element has the following attributes: