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Analytical methods, comprehensive analysis, 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 the reportable value from independent assay runs and use historic assay data to develop equivalence margins.
Reference information
Find reference information on the document types of the Biological Assay Package add-on.
Document elements
Find reference information on the document elements in the document types of the Biological Assay Package add-on.
A–D
Find reference information on document elements of the Dose-Response Analysis Package, letters A to D.
Absolute potency status

Get started
Overview of the PLA 3.0 software, its ongoing improvements and version updates, and the available trial options.
Key concepts
Structural foundation for daily work and support for method development from initial design to routine production.
Data analysis
Analytical methods, comprehensive analysis, 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 the reportable value from independent assay runs and use historic assay data to develop equivalence margins.
  - Installation
    Find details on the system requirements for the Biological Assay Package add-on and the steps to install the add-on in your environment.
  - Basic bioassay protocol
    Use Basic bioassay protocol documents to set up a workflow for producing reportable values from multiple independent assay runs. Organize complex methods, retest scenarios, and report several products in a single assay.
  - Combination of assay results
    Use Combination of assay results documents to perform combination calculations for independent assay runs, thus obtaining reportable values for the potency.
  - Equivalence margin development
    Use Equivalence margin development documents to develop and verify test systems based on historic assays and apply these test systems in new development of quantitative response assays.
  - Quantitative response assays
    Use Quantitative response assay documents to calculate the potencies of test samples relative to an established standard. You can also use them to determine absolute potencies based on stock solutions or raw materials.
  - Test system definition
    Use Test system definition documents of the Biological Assay Package to define a collection of suitability tests and corresponding margins for Quantitative response assay documents.
  - Use case: Automate a bioassay workflow
    For some biological assays, determining relative potency within a single run is not sufficient. In these cases, you perform multiple individual assay runs and then combine the resulting data to obtain a more reliable final potency estimate. The challenge is to combine these individual results efficiently and reproducibly, particularly in regulated environments or when preparing for automated workflows.
  - Reference information
    Find reference information on the document types of the Biological Assay Package add-on.
    - Basic bioassay protocol documents
      Find details on the document structure of Basic bioassay protocol and access reference information on particular document elements.
    - Combination of assay results documents
      Find details on the document structure of Combination of assay results and access reference information on particular document elements.
    - Equivalence margin development documents
      Find details on the document structure of Equivalence margin development and access reference information on particular document elements.
    - Quantitative response assay documents
      Find details on the document structure of Quantitative response assay and access reference information on particular document elements.
    - Test system definition documents
      Find details on the document structure of Test system definition and access reference information on particular document elements.
    - Document elements
      Find reference information on the document elements in the document types of the Biological Assay Package add-on.
      - A–D
        Find reference information on document elements of the Dose-Response Analysis Package, letters A to D.
        ANOVA block effects
        ANOVA model
        Absolute potency
        Absolute potency lower confidence limit
        Absolute potency status
        Absolute potency unit
        Absolute potency upper confidence limit
        Absolute potency: Defined by raw material
        Absolute potency: Defined by stock solution
        Absolute potency: Defined by template
        Absolute potency: Not defined
        Activated
        Additional tests
        Additional tests
        Adjustment
        Advanced settings
        Allow subfolder
        Allow subfolders
        Alpha
        Amount
        Amount (summary)
        Amount units
        Analysis
        Analysis
        Analytical model
        Assay element scope
        Assay element type scope
        Assay element type scope
        Assay element type scope
        Assay elements
        Assay purpose
        Assay replicate
        Assay replicate document
        Assay suitability tests
        Assay template
        Assay templates
        Assigned/assumed potency
        Assigned/assumed potency (summary)
        Assigned/assumed potency units
        Asymmetry parameter (G) (nonlinear models)
        Asymmetry parameter (G) (nonlinear models)
        Asymptote fixed by control line
        Asymptote fixed by value
        Author
        B parameter (nonlinear models)
        B parameter (nonlinear models)
        Base
        Basic bioassay protocol
        Block factor
        Block-based by Control line
        Block-based by Control line
        C parameter (nonlinear models)
        C parameter (nonlinear models)
        Calculate mean potency estimate of test samples
        Coefficient of determination
        Column key
        Column key
        Column key
        Column key
        Column: Assay element
        Column: Assay test state
        Column: Assignment
        Column: Boolean
        Column: Date
        Column: Date/time
        Column: Degrees of freedom
        Column: Document reference
        Column: Exclude assay
        Column: Exclude from analysis
        Column: Floating point number
        Column: Integer
        Column: Memo (multiline text)
        Column: Model
        Column: Observation group
        Column: Position factor
        Column: Potency confidence level
        Column: Response value
        Column: Scientifically acceptable
        Column: Section
        Column: Section
        Column: Sequence step
        Column: Technical-outlier flag
        Column: Text
        Column: Time
        Combination calculation
        Combination calculation (sample only)
        Combination calculation templates
        Combination document reference
        Combination of independent assay results
        Combination type
        Combination type based on homogeneity test
        Comment
        Compendial guidance
        Concentration unit
        Conditional evaluation
        Confidence level
        Confidence level (%)
        Confidence level (%)
        Config
        Config
        Config
        Configuration
        Configuration name
        Configuration name
        Configuration optimizer allocation range
        Control line
        Control line
        Control line
        Control sample
        Cov(A,D) standard sample
        Cov(A,D) test/control sample
        Covariances
        Creation time
        Data selection scheme
        Data selection scheme
        Data selection schemes
        Data source
        Data table
        Date
        Date
        Deactivate reduced accuracy fit
        Deactivated
        Defined sequence
        Degrees of freedom
        Delta
        Difference of asymptotes (A - D) (nonlinear models)
        Difference of asymptotes (A - D) (nonlinear models, Standard only)
        Difference of responses
        Dilution factor
        Display color
        Display horizontal lines
        Display legend
        Display vertical lines
        Dixon test
        Document mode
        Document name
        Document property filter
        Document property filter
        Document reference
        Document suitability tests
        Document type
        Document type
        Documentation
        Documentation
        Documentation
        Dose value
        by Control line
        by Control line
        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 Biological Assay Package add-on.
- 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.
- 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
Import of external response values and observation data into PLA 3.0 for further processing and evaluation.
User interface
The user interface of PLA 3.0 includes graphical and textual elements designed for daily workflows.
Installation and update
Deployment, installation, and update of PLA 3.0, including initial and advanced setup.
Licensing
The licensing solution of PLA 3.0, available licensing options, and the activation and management of licenses.
Administration
Setup and maintenance of databases and add-ons, user accounts, access rights, and migration and update procedures.
Regulatory compliance
PLA 3.0 supports users in achieving compliance with regulations such as ISPE GAMP^® 5 and 21 CFR Part 11.
Sample lab
Stegmann Labs serves as the sample lab for scenarios illustrating the use of PLA 3.0 across bioassay analysis workflows.
Glossary
Definitions of central terminology used in PLA 3.0.

Absolute potency status

This column indicates the test status of the combined absolute potency.


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

/Basic bioassay protocol/Reportable values/

Absolute potency status

This element has the following attributes: