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Data analysis
Analytical methods, comprehensive analysis, 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.
S–Z
Find reference information on document elements of the Dose-Response Analysis Package, letters S to Z.
Source

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.
- 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.
      - 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.
        (Externally) studentized residuals test
        Sample suitability tests
        Section key
        Section key
        Section property filter
        Section property import
        Sequence step
        Sequence step
        Settings
        Settings
        Setup
        Severity level of the test
        Show error bars
        Show observations
        Simulation space
        Single-dose scheme
        Slope (linear models)
        Solvent volume
        Source
        Square response transformation
        Square root response transformation
        Standard
        Standard deviation test
        Standard error: A upper asymptote (nonlinear models)
        Standard error: B parameter (nonlinear models)
        Standard error: C parameter (nonlinear models)
        Standard error: D lower asymptote (nonlinear models)
        Standard error: G asymmetry parameter (nonlinear models)
        Standard error: Intercept (linear models)
        Standard error: Slope (linear models)
        Step start
        Step stop
        Stepwise concentration sequence
        Stepwise dilution sequence
        Strategy
        Subject
        Substance batch/lot number
        Substance class
        Substance description
        Substance identification
        Substance name
        Substance reference
        Substance sub-batch/sub-lot number
        Substance variant
        Suitability tests
        Suitability tests
        Template key
        Term
        Test
        Test strategies
        Test strategy verification
        Test strategy visualization
        Test system for dose-response analysis
        Test system reference
        Test: Anova terms
        Test: Anova terms
        Test: Coefficient of determination (R²)
        Test: Effective concentration
        Test: Interval of interpolation
        Test: Maximal number of outliers
        Test: Maximal sequence step CV (%)
        Test: Mean squares (ANOVA)
        Test: Mean-squared lack of fit
        Test: Mean-squared model
        Test: Mean-squared pure error
        Test: Mean-squared residual error
        Test: Mean-squared total
        Test: Parameter/property point estimate
        Test: Parameter/property point estimate
        Test: Parameter/property point estimate
        Test: Recovery rate
        Test: Response at effective concentration
        Test: Response value range
        Test: Sum of squares (ANOVA)
        Test: Sum-of-squares lack of fit
        Test: Sum-of-squares model
        Test: Sum-of-squares pure error
        Test: Sum-of-squares residual error
        Test: Sum-of-squares total
        Test: Transduction unit
        Test: Value of interpolation
        Test: Width of interpolation interval
        Text
        Tolerance level
        Total number of cells
        Transduction unit
        Transformation
        Transformed dose maximum
        Transformed dose minimum
        Transformed dose range
        Type
        Type
        Type
        Type
        Type
        Type
        Unit
        Unit
        Unit
        Unit
        Unit
        Unit
        Update mode
        Update mode
        Upper asymptote fixed by sample
        Upper asymptote fixed by value
        Upper limit
        Upper margin
        Upper margin (calculated value)
        Upper margin (manual input)
        User variable
        Value
        Variance
        Visualization
        Width absolute
        Width relative
        Working concentration
    - 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
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.
Glossary
Definitions of central terminology used in PLA 3.0.

Source

Links this document to the source Equivalence margin development document.


Data type	Multiplicity	Usage	Default value
Node	0...1	optional	none

/Test system for dose-response analysis/

Source

This element has the following attributes: