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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.
M–R
Find reference information on document elements of the Dose-Response Analysis Package, letters M to R.
Reagent class

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.
      - 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.
        Map index to characters
        Margin development
        Margin development
        Margin symmetry assumption
        Margin symmetry assumption
        Max configurations
        Max simulations
        Maximal group number
        Meaning
        Minimal number of steps
        Mode: Assay element
        Mode: Assay replicate
        Model
        Model: 3-parameter logistic fit with fixed lower asymptote
        Model: 3-parameter logistic fit with fixed upper asymptote
        Model: 4-parameter logistic fit
        Model: 5-parameter logistic fit
        Model: Linear parallel-line
        Model: Slope ratio
        Name
        Name
        Name
        Name
        Name
        Name
        Name
        Name
        Name
        Name
        Name
        No adjustment
        No normalization
        No outlier detection
        No transformation
        No. of dilution factor
        Normalization
        Number of positions
        Number of replicates
        Number of replicates
        Number of signatures
        Number of steps
        Observation data
        Observation group ID
        Observation group ID
        Observation source
        Observation source
        Observation source
        Operational sequence
        Operator
        Operator name
        Operator reference
        Optimization off
        Optimization on
        Outlier processing
        Parameter
        Parameter
        Point estimate test: Difference of parameter estimates
        Point estimate test: Parameter estimate
        Point estimate test: Ratio of parameter estimates
        Point estimate tests: Difference of parameter estimates
        Point estimate tests: Difference of parameter estimates
        Point estimate tests: Parameter estimate
        Point estimate tests: Parameter estimate
        Point estimate tests: Ratio of parameter estimates
        Point estimate tests: Ratio of parameter estimates
        Potency confidence interval calculation method
        Potency data
        Potency estimation confidence level
        Potency type
        Potency type
        Predilution factor
        Predilution factors
        Predilution factors: Defined by template
        Predilution factors: Manual input
        Preparation scheme
        Preparation scheme
        Preparation schemes
        Property filter
        Property key
        Property key
        Property scope
        Protect observation group ID
        Quality weight
        Quantitative response assay
        Range full
        Range partial
        Ratio of asymptotes (A / D) (nonlinear models)
        Reagent
        Reagent batch/lot number
        Reagent class
        Reagent description
        Reagent identification
        Reagent name
        Reagent reference
        Reagent sub-batch/sub-lot number
        Reagent variant
        Recursive
        Reference mean (calculated value)
        Reference mean (manual input)
        Relative potency
        Relative potency lower confidence limit
        Relative potency status
        Relative potency upper confidence limit
        Replicate averaging
        Replicate count
        Report excluded/invalid elements
        Reportable values
        Response data processing
        Response maximum
        Response minimum
        Response range
        Response value lower limit
        Response value upper limit
        Restrict selection
        Role
        Rounding
        Rounding
        Row order
        n Sigma
        p
      - 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.

Reagent class

Enter the class of the reagent such as the drug class.


Data type	Multiplicity	Usage	Default value
xs:token	0...1	optional	none

/Quantitative response assay/Documentation/Reagent/

Reagent class

This element has the following attributes: