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

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.
        Map index to characters
        Margin development
        Margin development
        Max configurations
        Max simulations
        Maximal group number
        Maximal response
        Model
        Model: 2-parameter logistic fit with fixed asymptotes
        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: Hill equation
        Model: Linear
        Multi-dose scheme
        Name
        Name
        Name
        Name
        Name
        Name
        Name
        Name
        Name
        Name
        No adjustment
        No dose transformation
        No dose transformation
        No normalization
        No outlier detection
        No transformation
        Normalization
        Number of positions
        Number of replicates
        Number of steps
        Numerical value
        Numerical value
        Numerical value
        Numerical value
        Observation data
        Observation group ID
        Observation source
        Observation source
        Operational sequence
        Operator
        Operator name
        Operator reference
        Outlier processing
        Parameter
        Percentile
        Percentile
        Plate scope
        Predilution factor
        Predilution factors
        Predilution factors
        Preparation scheme
        Preparation scheme
        Preparation schemes
        Property filter
        Property key
        Property key
        Property key
        Property key
        Property key
        Property scope
        Range partial
        Reagent
        Reagent batch/lot number
        Reagent class
        Reagent description
        Reagent identification
        Reagent name
        Reagent reference
        Reagent sub-batch/sub-lot number
        Reagent variant
        Recursive
        Replicate averaging
        Report group
        Report group
        Report groups
        Response data processing
        Response maximum
        Response minimum
        Response range
        Response range
        Role
        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 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.

Name

Enter a name for the test strategy.


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

/Equivalence margin development (Dose-response analysis)/Test strategies/Strategy/

Name

This element has the following attributes: